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Der Einfluss des Ernährungsmusters auf die erektile Funktion (ERECTION)

22. Juli 2026 aktualisiert von: Montefiore Medical Center

Der Einfluss einer pflanzlichen Ernährung im Vergleich zu einer tierischen Ernährung auf die erektile Funktion bei gesunden Männern mit normaler erektiler Funktion: Die ERECTION-Studie

Das Ziel dieser Studie ist es festzustellen, ob die erektile Funktion durch Ernährungsgewohnheiten bei gesunden Männern mit normaler erektiler Funktion beeinflusst wird.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Besuch 1:

Nach Überprüfung und Unterzeichnung der Einwilligung werden die Probanden überprüft. Das Screening besteht aus:

Füllen Sie den IIEF (International Index of Erectile Function) und einen Ernährungsfragebogen aus.

Notieren Sie die Krankengeschichte, Medikamente. Messen Sie Größe und Gewicht

Wenn der IIEF-Score abnormal ist, wird den Probanden geraten, sich an PCP (Primary Care Provider) zu wenden.

Die Probanden werden mit Labortestergebnissen kontaktiert. Falls anormal, wird dem Patienten geraten, sich an PCP zu wenden.

Wenn der Proband keinen PCP hat, werden Kontaktinformationen für einen PCP angegeben. Probanden, die die Einschluss- und Ausschlusskriterien erfüllen, werden randomisiert entweder in Sequenz eins oder Sequenz zwei eingeteilt. Nach der Registrierung werden die Probanden ihre Ernährungsgewohnheiten während der gesamten Dauer der Studie nicht ändern, außer während der zwei Abende und zwei vollen Tage, an denen Essen bereitgestellt wird (siehe unten).

Folge eins:

Besuch 2:

Die Probanden kehren morgens in das Studienzentrum zurück, nachdem sie seit 23:00 Uhr in der Nacht zuvor gefastet haben (außer dem Konsum von Wasser). Die Probanden werden sich an diesem Morgen nicht die Zähne putzen oder Mundwasser und/oder andere Atemerfrischer verwenden. Anthropomorphe, Blutdruck- und Herzfrequenzaufzeichnungen werden gemacht. Blut wird abgenommen und aufbewahrt. Der Urin wird gesammelt und aufbewahrt. Den Probanden wird die Verwendung des Rigiscan™-Geräts beigebracht. Die Probanden erhalten ein pflanzliches Abendessen. Die Probanden verlassen dann das Studienzentrum und nehmen bis 17:00 Uhr die übliche Diät zu sich. Für den Rest des Abends bis 23:00 Uhr konsumieren die Probanden nur das bereitgestellte Abendessen. Wasser ist das einzige Getränk, das nach 17:00 Uhr erlaubt ist. Das Abendessen sollte um 20:30 Uhr EST (Eastern Standard Time) eingenommen werden. Die Probanden senden nach 17:00 Uhr Bilder von allem, was gegessen oder getrunken wird, per SMS an den PI oder an einen Studienvertreter. Ein Mitglied des Studienteams wird mindestens einmal an diesem Abend Text- oder mündlichen Kontakt mit dem Probanden haben. Die Probanden werden nach 23:00 Uhr außer Wasser fasten. An diesem Abend führen die Probanden über Nacht zu Hause eine Rigiscan™-Bewertung durch. Die Zeit, zu der die Person zu Bett geht, und die Zeit, zu der die Person für den Tag aufwacht, sollten aufgezeichnet werden. Der Proband erklärt sich damit einverstanden, mindestens sieben Stunden lang mit eingeschaltetem Rigiscan™ im Bett zu bleiben (außer für Notfälle oder notwendige Toilettengänge).

Besuch 3:

Die Probanden kehren am Morgen nach der Rigiscan™-Beurteilung zum Studienzentrum zurück und bringen das Rigiscan™-Gerät mit. Die Probanden werden seit 23:00 Uhr in der Nacht zuvor etwas anderes als Trinkwasser gefastet haben. Die Probanden werden an diesem Morgen keine Zähne putzen oder Mundwasser und/oder andere Atemerfrischer verwenden. Anthropomorphe, Blutdruck- und Herzfrequenzaufzeichnungen werden gemacht. Blut wird abgenommen und aufbewahrt. Der Urin wird gesammelt und aufbewahrt. Die Probanden erhalten dann einen ganzen Tag lang pflanzliche Mahlzeiten. Die Probanden werden ermutigt, im Studienzentrum zu frühstücken, nachdem die anfänglichen anthropomorphen Maßnahmen durchgeführt, Blut entnommen und Urin gesammelt wurden. Die Probanden senden dem PI und/oder einem Studienvertreter Bilder von allem, was an diesem Tag konsumiert wird, per SMS, und ein Mitglied des Studienteams wird an diesem Tag mindestens zweimal Text- oder mündlichen Kontakt mit dem Probanden haben. Das Abendessen sollte um 20:30 Uhr EST eingenommen werden. Die Probanden werden nach 23:00 Uhr außer Wasser fasten. An diesem Abend führen die Probanden über Nacht zu Hause eine Rigiscan™-Bewertung durch. Schwarzer Kaffee und/oder Tee ist nur vor Mittag gestattet. Die Zeit, zu der die Person zu Bett geht, und die Zeit, zu der die Person für den Tag aufwacht, sollten aufgezeichnet werden. Der Proband erklärt sich damit einverstanden, mindestens sieben Stunden lang mit eingeschaltetem Rigiscan™ im Bett zu bleiben (außer für Notfälle oder notwendige Toilettengänge).

Besuch 4:

Die Probanden kehren am Morgen nach der Rigiscan™-Beurteilung zum Studienzentrum zurück und bringen das Rigiscan™-Gerät mit. Die Probanden werden an diesem Morgen keine Zähne putzen oder Mundwasser und/oder andere Atemerfrischer verwenden. Anthropomorphe, Blutdruck- und Herzfrequenzaufzeichnungen werden gemacht. Blut wird abgenommen und aufbewahrt. Der Urin wird gesammelt und aufbewahrt. Anschließend findet eine Auswaschphase von 8–12 Tagen statt, und die Probanden werden angewiesen, während dieser Auswaschphase zu ihren üblichen Ernährungsgewohnheiten zurückzukehren.

Besuch 5:

Nach der Auswaschphase kehren die Probanden am Morgen zum Studienzentrum zurück, nachdem sie seit 23:00 Uhr in der Nacht zuvor gefastet haben (abgesehen von der Einnahme von Wasser). Die Probanden werden an diesem Morgen keine Zähne putzen oder Mundwasser und/oder andere Atemerfrischer verwenden. Anthropomorphe, Blutdruck- und Herzfrequenzaufzeichnungen werden gemacht. Blut wird abgenommen und aufbewahrt. Der Urin wird gesammelt und aufbewahrt. Die Probanden erhalten ein Abendessen auf Tierbasis. Die Probanden verlassen dann das Studienzentrum und nehmen bis 17:00 Uhr die übliche Diät zu sich. Für den Rest des Abends bis 23:00 Uhr konsumieren die Probanden nur das bereitgestellte Abendessen. Wasser ist das einzige Getränk, das nach 17:00 Uhr konsumiert wird. Das Abendessen sollte um 20:30 Uhr EST eingenommen werden. Die Probanden senden nach 17:00 Uhr Bilder von allem, was konsumiert wird (essen oder trinken), per SMS an den PI oder an einen Studienvertreter, und ein Mitglied des Studienteams wird an diesem Abend mindestens einmal Text- oder mündlichen Kontakt mit dem Probanden haben. Die Probanden werden nach 23:00 Uhr außer Wasser fasten. An diesem Abend führen die Probanden über Nacht zu Hause eine Rigiscan™-Bewertung durch. Die Zeit, zu der die Person zu Bett geht, und die Zeit, zu der die Person für den Tag aufwacht, sollten aufgezeichnet werden. Der Proband erklärt sich damit einverstanden, mindestens sieben Stunden lang mit eingeschaltetem Rigiscan™ im Bett zu bleiben (außer für Notfälle oder notwendige Toilettengänge).

Besuch 6:

Die Probanden kehren am Morgen nach der Rigiscan™-Beurteilung zum Studienzentrum zurück und bringen das Rigiscan™-Gerät mit. Die Probanden werden an diesem Morgen keine Zähne putzen oder Mundwasser und/oder andere Atemerfrischer verwenden. Anthropomorphe, Blutdruck- und EndoPAT™-Aufzeichnungen werden gemacht. Speichel wird gespeichert. Blut wird abgenommen und aufbewahrt. Die Probanden erhalten dann einen ganzen Tag lang tierische Mahlzeiten. Die Probanden werden ermutigt, im Studienzentrum zu frühstücken, nachdem die anfänglichen anthropomorphen Maßnahmen durchgeführt, Speichel gewonnen und Blut entnommen wurden. Die Probanden senden dem PI und/oder einem Studienvertreter Bilder von allem, was an diesem Tag konsumiert wird, per SMS, und das Studienteam wird an diesem Tag mindestens zweimal Text- oder mündlichen Kontakt mit dem Probanden haben. Das Abendessen sollte um 20:30 Uhr EST eingenommen werden. Die Probanden werden nach 23:00 Uhr außer Wasser fasten. An diesem Abend führen die Probanden über Nacht zu Hause eine Rigiscan™-Bewertung durch. Schwarzer Kaffee und/oder Tee ist nur vor Mittag gestattet. Die Zeit, zu der die Person zu Bett geht, und die Zeit, zu der die Person für den Tag aufwacht, sollten aufgezeichnet werden. Der Proband erklärt sich damit einverstanden, mindestens sieben Stunden lang mit eingeschaltetem Rigiscan™ im Bett zu bleiben (außer für Notfälle oder notwendige Toilettengänge).

Besuch 7 (Studienende):

Die Probanden kehren am Morgen nach der Rigiscan™-Beurteilung zum Studienzentrum zurück und bringen das Rigiscan™-Gerät mit. Die Probanden werden an diesem Morgen keine Zähne putzen oder Mundwasser und/oder andere Atemerfrischer verwenden. Anthropomorphe, Blutdruck- und Herzfrequenzaufzeichnungen werden gemacht. Blut wird abgenommen und aufbewahrt. Der Urin wird gesammelt und aufbewahrt.

Folge zwei:

Sequenz zwei ist identisch mit Sequenz eins, außer dass tierische Mahlzeiten anstelle von pflanzlichen Mahlzeiten bereitgestellt werden. Für Probanden, die in Sequenz Eins und Sequenz Zwei zu Mahlzeiten auf Tierbasis randomisiert wurden, sind identisch, außer dass Mahlzeiten auf Pflanzenbasis anstelle von Mahlzeiten auf Tierbasis bereitgestellt werden.

Studientyp

Interventionell

Einschreibung (Geschätzt)

46

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • New York
      • The Bronx, New York, Vereinigte Staaten, 10467
        • Rekrutierung
        • Montefiore Medical Center, Department of Medicine, Division of Cardiology
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

14 Jahre bis 25 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Einschlusskriterien:

  • Der Proband gibt eine schriftliche Einverständniserklärung und eine HIPAA-Autorisierung in englischer Sprache vor, bevor Studienverfahren durchgeführt werden;
  • Keine medizinische Therapie (außer prn MDIs (Dosierinhalatoren) und keine Änderung der Nahrungsergänzungsmittel, falls zutreffend)
  • IIEF-Score größer oder gleich 22
  • Das Subjekt muss innerhalb von 4 Wochen nach der Registrierung Penis-Vaginal-Sex gehabt haben. Der verwendete IIEF-Score wird basierend auf diesem Zeitfenster validiert.
  • Männlich im Alter von 18-29 Jahren
  • Lebt in Pendeldistanz zum Gesundheitssystem von Montefiore
  • Die Lebensgefährtin des Studienteilnehmers (falls zutreffend) erklärt sich bereit, den Studienteilnehmer während der Studie zu unterstützen
  • Der Proband erklärt sich damit einverstanden, alle während der Ernährungsintervention konsumierten/getrunkenen Gegenstände zu fotografieren und zu teilen
  • Der Proband stimmt zu, alle illegalen Drogen, NSAIDs und Alkohol mindestens zwei Tage vor der Rigiscan™-Aufzeichnung und an den Tagen und Nächten der Rigiscan™-Aufzeichnung zu vermeiden
  • Der Proband stimmt zu, mindestens 36 Stunden vor der Rigiscan™-Einlage auf sexuelle Aktivitäten zu verzichten und an den Tagen und Nächten der Rigiscan™-Aufzeichnung keine sexuellen Aktivitäten zu haben.
  • Der Betreff stimmt zu, erotisches oder pornografisches Material für mindestens 36 Stunden vor den Tagen und Nächten der Rigiscan™-Aufzeichnung und an den Tagen und Nächten der Rigiscan™-Aufzeichnung nicht anzusehen, zu lesen oder anderweitig zu konsumieren
  • Der Proband stimmt zu, nach Montefiore zu kommen, um sich dem Rigiscan™-Training zu unterziehen
  • Der Proband verpflichtet sich, nur erlaubte Speisen/Getränke zu konsumieren/trinken.
  • Der Proband stimmt zu, an allen persönlichen Besuchen in Montefiore teilzunehmen, in der Nacht vor jedem Besuch um 23:00 Uhr mit dem Fasten zu beginnen und sich allen Blutentnahmen/Speichel-/anderen Tests zu unterziehen.
  • Der Proband stimmt zu, während der gesamten Dauer der Studie kein Mundwasser oder Mundspülungen zu verwenden oder absichtlich zu spucken. Die Probanden werden gebeten, mindestens 2 Tage vor der Einschreibung auf die Verwendung von Mundwasser zu verzichten. Der Proband stimmt zu, seine Zähne am Morgen des Tages jedes Studienbesuchs nicht zu putzen. Ansonsten ist das Zähneputzen erlaubt.
  • BMI kleiner als 30, BMI größer oder gleich 18,5, Gewicht größer als 110 lbs.
  • Der Proband stimmt zu, die Studienverfahren und Besuche einzuhalten.
  • Fachübungen für mindestens 15 Minuten mindestens zweimal pro Woche. Der Proband erklärt sich damit einverstanden, am Tag vor und am Tag der Rigiscan™-Messungen auf körperliche Betätigung zu verzichten

Ausschlusskriterien:

  • Relevante Nahrungsmittelallergie
  • Vegetarisches oder veganes Ernährungsmuster
  • Vorgeschichte einer Essstörung; Beweise für eine Esssucht
  • Hypertonie und/oder Hypertonie in der Anamnese mit oder ohne medizinische Behandlung
  • BMI größer oder gleich 30, BMI kleiner als 18,5 oder Gewicht kleiner oder gleich 110 Pfund
  • Bekannte chronische medizinische Erkrankung außer nicht entzündlichen Erkrankungen des Bewegungsapparates und Asthma
  • Anamnese einer Nierenerkrankung oder Hyperkaliämie
  • Das Subjekt hat innerhalb von 30 Tagen vor Unterzeichnung der Einwilligung ein Prüfpräparat erhalten
  • Erektile Dysfunktion
  • Hat einen Zustand (z. B. psychiatrische Erkrankung) oder eine Situation, die nach Ansicht des Prüfarztes die Studienergebnisse verfälschen oder die Fähigkeit des Patienten, die Studienverfahren einzuhalten, erheblich beeinträchtigen kann
  • Derzeit in Behandlung wegen der Peyronie-Krankheit
  • Anormaler Testosteron- oder Schilddrüsen-stimulierender Hormonspiegel
  • Behandelter Hypogonadismus oder Hypothyreose
  • Geplante Reisen während des Studiums
  • Geschichte des Drogenmissbrauchs in den letzten 12 Monaten
  • Konsum illegaler Drogen, Rauchen oder Dampfen innerhalb von 4 Wochen
  • Erkrankung der oberen Atemwege innerhalb von zwei Wochen beim Screening
  • Bei berufsbedingter Rufbereitschaft keine Nacht- oder Rufbereitschaft während des Studiums
  • Jede übertragbare Haut- oder Geschlechtskrankheit. Das Subjekt berichtet über Ausschlag oder Läsionen am Penis oder in der Umgebung. Das Subjekt wird gefragt: "Haben Sie einen Ausschlag oder eine Läsion an Ihrem Penis oder in der Umgebung?"

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Arm auf pflanzlicher Basis
Der pflanzenbasierte Arm besteht aus drei Besuchen im klinischen Forschungszentrum, bei dem man sich pflanzlich ernährt und das Rigiscan™-Gerät verwendet, um die Häufigkeit, Steifheit und Dauer nächtlicher Erektionen zu messen.
Sonstiges: Pflanzliche Ernährung
Das Essen wird von Montefiore-Einstein Food Services bereitgestellt
Aktiver Komparator: Tierischer Arm
Der tierbasierte Arm besteht aus drei Besuchen im klinischen Forschungszentrum, einer tierbasierten Diät und der Verwendung des Rigiscan™-Geräts zur Messung der Häufigkeit, Steifheit und Dauer nächtlicher Erektionen.
Sonstiges: Tierische Ernährung
Das Essen wird von Montefiore-Einstein Food Services bereitgestellt

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
Zeitfenster: During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal.
Zeitfenster: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals, where each erection lasts >=5 minutes as measured by Rigiscan™
Zeitfenster: During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal, where each erection lasts >=5 minutes as measured by Rigiscan™
Zeitfenster: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Heart rate
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing heart rate by dietary pattern at both time points (after overnight Rigiscan™ use after consuming the 1 meal and after overnight Rigiscan™ use after consuming the 4 meals) and compared to its respective baseline in beats/minute. Definition: In regard to the following anthropometric, vital sign, and laboratory data (blood, urine, and saliva) pre-specified outcomes included in this pre-specified outcomes section, at "both time points" is defined as in the sentence above and "respective baseline" refers to either visit 2 or visit 5, as visit 2 is the baseline for one dietary arm (plant or animal) and visit 5 is the baseline for the other dietary arm (plant or animal).
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Blood Pressure
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing blood pressure by dietary pattern at both time points and compared to its respective baseline in mmHg
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Weight
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing weight by dietary pattern at both time points and compared to its respective baseline
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Fibrinogen
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
D-dimer
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Total cholesterol
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
HDL cholesterol
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
HDL efflux capacity
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline.
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
LDL cholesterol
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Triglyceride
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Oxidized LDL cholesterol
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in U/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Free Fatty Acids
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Myeloperoxidase
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ug/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Factor VII
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in percentage.
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
lysolecithin
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Apolipoprotein B
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Omega 3 index
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in percentage of erythrocyte fatty acid
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Lipoprotein-associated phospholipase-A2 (Lp PLA2) activity
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/min/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Lipoprotein (a)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Homocysteine
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
methylmalonic acid (MMA)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Asymmetric Dimethylarginine (ADMA)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
symmetric dimethylarginine (SDMA)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Total testosterone
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Sex Hormone Binding Globulin
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in nmol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
cystatin C
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
remnant cholesterol particles
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
uric acid
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
interleukin 1
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in pg/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
interleukin 6
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in pg/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
hsCRP
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Blood Urea Nitrogen (BUN)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Carbon Dioxide (CO2)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mmol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
creatinine
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
glucose
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
serum chloride
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
serum potassium
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
serum sodium
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in meq/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
alanine aminotransferase (ALT)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in units/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
aspartate aminotransferase (AST)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in units/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
estimated glomerular filtration rate (eGFR)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mL/min/1.73m2
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
vitamin c
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/dL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
reduced glutathione
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
superoxide dismutase
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
vitamin e
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
selenium
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in ng/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
malondialdehyde
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
non coding RNA
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
micro RNA
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Lnc RNA
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in copies/mL
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
trimethylamine-N-oxide (TMAO)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in umol/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
phenylacetylglutamine (PAG)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in uM (micrometers)
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing urine albumin-to-creatinine ratio (UACR)
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in mg/g
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing salivary nitrite level as a correlate of plasma nitric oxide (NO) level
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing salivary nitrate level in as a correlate of plasma nitric oxide (NO) level
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in micromoles/L
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Platelets
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline in cells/ul.
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
FIB-4 Index
Zeitfenster: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Comparing it at both time points by dietary pattern and compared to its respective baseline
Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 day washout (Visit 5), at ~24 hours after 8-12 day washout (Visit 6), at ~48 hours after 8-12 day washout (Visit 7)
Percent of time ≥50% erect during overnight Rigiscan™ use after the 4 meals.
Zeitfenster: During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥50% erect during overnight Rigiscan™ use after 1 meal.
Zeitfenster: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use)
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use)
Percent of time ≥70% erect during overnight Rigiscan™ use after 4 meals.
Zeitfenster: During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming the 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥70% erect during overnight Rigiscan™ use after 1 meal.
Zeitfenster: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
Percent of time ≥70% erect during overnight Rigiscan™ use after 4 meals versus after 1 meal by dietary pattern.
Zeitfenster: During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals versus after 1 meal by dietary pattern.
Zeitfenster: During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 60% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
Percent of time ≥50% erect during overnight Rigiscan™ use after 4 meals versus after 1 meal by dietary pattern.
Zeitfenster: During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming the 4 meals versus overnight Rigiscan™ use directly after consuming the 1 meal by dietary pattern, for each dietary pattern.
Percent of time ≥70% erect during overnight Rigiscan™ use after 4 meals, where each erection lasts >=5 minutes as measured by Rigiscan™
Zeitfenster: During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 70% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥70% erect during overnight Rigiscan™ use after 1 meal, where each erection lasts >=5 minutes as measured by Rigiscan™
Zeitfenster: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥70% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
Percent of time ≥50% erect during overnight Rigiscan™ use after 4 meals, where each erection lasts >=5 minutes as measured by Rigiscan™
Zeitfenster: During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 4 meals. (The second night of Rigiscan™ use).
Percent of time ≥50% erect during overnight Rigiscan™ use after 1 meal, where each erection lasts >=5 minutes as measured by Rigiscan™
Zeitfenster: During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).
The first 5 minutes of Rigiscan™ recording is discarded. Erection time is the total time (in minutes) when penile rigidity is ≥ 50% at both the tip and the base of the penis with a concurrent increase in penile tumescence at both the tip and base of the penis compared to baseline tumescence, and the erection lasts >= 5 minutes, as measured by Rigiscan™ during overnight Rigiscan™ use, divided by the total time (in minutes) of overnight Rigiscan™ use. Overnight Rigiscan™ use time is defined as starting 5 minutes after the start of the Rigiscan™ recording and the end of Rigiscan™ use is defined as the last time the tip or base was >=10% rigid with a corresponding concurrent increase in penile tumescence at the tip or base compared to baseline tumesence. This total time window from start to end is the Rigiscan™ use time.
During overnight Rigiscan™ use directly after consuming 1 meal. (The first night of Rigiscan™ use).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Montefiore Medical Center

Mitarbeiter

National Institutes of Health (NIH)
Nitric Oxide Innovations LLC
The Purjes Foundation
The Greenbaum Foundation
Dr. Irwin Goldstein

Ermittler

  • Hauptermittler: Robert Ostfeld, MD, Montefiore Medical Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Oktober 2023

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

27. März 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. April 2020

Zuerst gepostet (Tatsächlich)

16. April 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2019-10465

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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