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De impact van het voedingspatroon op de erectiele functie (ERECTION)

22 juli 2026 bijgewerkt door: Montefiore Medical Center

De impact van een plantaardig dieet versus een dierlijk dieet op de erectiele functie bij gezonde mannen met een normale erectiele functie: de ERECTION-studie

Het doel van deze studie is om te bepalen of de erectiele functie wordt beïnvloed door voedingspatronen bij gezonde mannen met een normale erectiele functie.

Studie Overzicht

Toestand

Werving

Gedetailleerde beschrijving

Bezoek 1:

Na beoordeling en ondertekening van toestemming worden proefpersonen gescreend. De screening zal bestaan ​​uit:

Voltooi IIEF (International Index of Erectile Function) en een voedselfrequentievragenlijst.

Registreer medische geschiedenis, medicijnen Lengte en gewicht meten Vitals Bloed afnemen voor totaal testosteron, geslachtshormoon-afhankelijk globuline en TSH (schildklierstimulerend hormoon) Proefpersonen zullen worden ondervraagd over de aanwezigheid van genitale huiduitslag of laesies

Als de IIEF-score abnormaal is, wordt proefpersonen geadviseerd contact op te nemen met PCP (eerstelijnszorgverlener).

Onderwerpen zullen worden gecontacteerd met laboratoriumtestresultaten. Indien abnormaal, wordt de patiënt geadviseerd om contact op te nemen met PCP.

Als de proefpersoon geen PCP heeft, worden contactgegevens voor een PCP gegeven. Proefpersonen die aan de in- en uitsluitingscriteria voldoen, worden gerandomiseerd in reeks één of reeks twee. Eenmaal ingeschreven, zullen proefpersonen tijdens de duur van het onderzoek hun voedingsgewoonten niet wijzigen, behalve tijdens de twee avonden en twee volle dagen waarop voedsel wordt verstrekt (zie hieronder).

Volgorde één:

Bezoek 2:

De proefpersonen keren 's ochtends terug naar het onderzoekscentrum nadat ze de avond ervoor vanaf 23.00 uur hebben gevast (anders dan het drinken van water). Proefpersonen zullen die ochtend hun tanden niet poetsen of mondwater en/of andere ademverfrissers gebruiken. Er worden antropomorfe, bloeddruk- en hartslagopnamen gemaakt. Er wordt bloed afgenomen en opgeslagen. Urine wordt opgevangen en opgeslagen. De proefpersonen leren hoe ze het Rigiscan™-apparaat moeten gebruiken. Proefpersonen krijgen één plantaardig diner. De proefpersonen zullen dan het studiecentrum verlaten en tot 17.00 uur hun gebruikelijke dieet volgen. De rest van de avond tot 23.00 uur zullen proefpersonen alleen het verstrekte diner nuttigen. Water is de enige drank die na 17.00 uur is toegestaan. Het diner moet om 20:30 uur EST (Eastern Standard Time) worden genuttigd. Proefpersonen sms'en foto's van alles wat wordt geconsumeerd (eten of drinken) na 17.00 uur naar de PI of naar een studievertegenwoordiger. Een lid van het onderzoeksteam zal minstens één keer die avond tekst- of mondeling contact hebben met de proefpersoon. Onderwerpen zullen na 23.00 uur anders dan water vasten. Die avond zullen de proefpersonen 's nachts thuis een Rigiscan™-beoordeling uitvoeren. De tijd waarop de proefpersoon naar bed gaat en de tijd waarop de proefpersoon overdag wakker wordt, moet worden geregistreerd. De proefpersoon stemt ermee in om gedurende ten minste zeven uur in bed te liggen met Rigiscan™ aan (behalve voor noodgevallen of noodzakelijke uitstapjes naar de badkamer).

Bezoek 3:

De proefpersonen keren de ochtend na de Rigiscan™-beoordeling terug naar het onderzoekscentrum en brengen het Rigiscan™-apparaat mee. De proefpersonen hebben sinds 23.00 uur de avond ervoor gevast, afgezien van het drinken van water. De proefpersonen zullen die ochtend geen tanden poetsen of mondwater en/of andere ademverfrissers gebruiken. Er worden antropomorfe, bloeddruk- en hartslagopnamen gemaakt. Er wordt bloed afgenomen en opgeslagen. Urine wordt opgevangen en opgeslagen. De proefpersonen krijgen dan een volledige dag plantaardige maaltijden. Proefpersonen zullen worden aangemoedigd om te ontbijten in het studiecentrum nadat de eerste antropomorfe maatregelen zijn genomen, bloed is afgenomen en urine is verzameld. Proefpersonen sms'en foto's van alles wat gedurende die dag wordt geconsumeerd naar de PI en/of een studievertegenwoordiger en een lid van het onderzoeksteam zal gedurende die dag ten minste tweemaal tekst- of mondeling contact met de proefpersoon hebben. Het diner moet om 20.30 uur worden geconsumeerd, EST. Onderwerpen zullen na 23.00 uur anders dan water vasten. Die avond zullen de proefpersonen 's nachts thuis een Rigiscan™-beoordeling uitvoeren. Zwarte koffie en/of thee is alleen toegestaan ​​voor de middag. De tijd waarop de proefpersoon naar bed gaat en de tijd waarop de proefpersoon overdag wakker wordt, moet worden geregistreerd. De proefpersoon stemt ermee in om gedurende ten minste zeven uur in bed te liggen met Rigiscan™ aan (behalve voor noodgevallen of noodzakelijke uitstapjes naar de badkamer).

Bezoek 4:

De proefpersonen keren de ochtend na de Rigiscan™-beoordeling terug naar het onderzoekscentrum en brengen het Rigiscan™-apparaat mee. De proefpersonen zullen die ochtend geen tanden poetsen of mondwater en/of andere ademverfrissers gebruiken. Er worden antropomorfe, bloeddruk- en hartslagopnamen gemaakt. Er wordt bloed afgenomen en opgeslagen. Urine wordt opgevangen en opgeslagen. Er zal dan een wash-outperiode van 8-12 dagen zijn en proefpersonen zullen worden geïnstrueerd om tijdens deze wash-outperiode terug te keren naar de gebruikelijke voedingsgewoonten.

Bezoek 5:

Na de wash-out-periode keren de proefpersonen 's ochtends terug naar het studiecentrum nadat ze de avond ervoor vanaf 23.00 uur hadden gevast (anders dan het nuttigen van water). De proefpersonen zullen die ochtend geen tanden poetsen of mondwater en/of andere ademverfrissers gebruiken. Er worden antropomorfe, bloeddruk- en hartslagopnamen gemaakt. Er wordt bloed afgenomen en opgeslagen. Urine wordt opgevangen en opgeslagen. Proefpersonen krijgen één dierlijk diner. De proefpersonen zullen dan het studiecentrum verlaten en tot 17.00 uur hun gebruikelijke dieet volgen. De rest van de avond tot 23.00 uur zullen proefpersonen alleen het verstrekte diner nuttigen. Water is de enige drank die na 17.00 uur wordt genuttigd. Het diner moet om 20.30 uur worden geconsumeerd, EST. Proefpersonen sms'en foto's van alles wat wordt geconsumeerd (eten of drinken) na 17.00 uur naar de PI of naar een studievertegenwoordiger en een lid van het onderzoeksteam zal minstens één keer die avond tekst- of mondeling contact hebben met de proefpersoon. Onderwerpen zullen na 23.00 uur anders dan water vasten. Die avond zullen de proefpersonen 's nachts thuis een Rigiscan™-beoordeling uitvoeren. De tijd waarop de proefpersoon naar bed gaat en de tijd waarop de proefpersoon overdag wakker wordt, moet worden geregistreerd. De proefpersoon stemt ermee in om gedurende ten minste zeven uur in bed te liggen met Rigiscan™ aan (behalve voor noodgevallen of noodzakelijke uitstapjes naar de badkamer).

Bezoek 6:

De proefpersonen keren de ochtend na de Rigiscan™-beoordeling terug naar het onderzoekscentrum en brengen het Rigiscan™-apparaat mee. De proefpersonen zullen die ochtend geen tanden poetsen of mondwater en/of andere ademverfrissers gebruiken. Er worden antropomorfe, bloeddruk- en EndoPAT™-opnamen gemaakt. Speeksel wordt opgeslagen. Er wordt bloed afgenomen en opgeslagen. De proefpersonen krijgen dan een volledige dag maaltijden op basis van dieren. Proefpersonen zullen worden aangemoedigd om te ontbijten in het studiecentrum nadat de eerste antropomorfe maatregelen zijn genomen, speeksel is verkregen en bloed is afgenomen. Proefpersonen sturen foto's van alles wat gedurende die dag wordt geconsumeerd naar de PI en/of een studievertegenwoordiger en het onderzoeksteam zal gedurende die dag ten minste tweemaal tekst- of mondeling contact met de proefpersoon hebben. Het diner moet om 20.30 uur worden geconsumeerd, EST. Onderwerpen zullen na 23.00 uur anders dan water vasten. Die avond zullen de proefpersonen 's nachts thuis een Rigiscan™-beoordeling uitvoeren. Zwarte koffie en/of thee is alleen toegestaan ​​voor de middag. De tijd waarop de proefpersoon naar bed gaat en de tijd waarop de proefpersoon overdag wakker wordt, moet worden geregistreerd. De proefpersoon stemt ermee in om gedurende ten minste zeven uur in bed te liggen met Rigiscan™ aan (behalve voor noodgevallen of noodzakelijke uitstapjes naar de badkamer).

Bezoek 7 (eind studie):

De proefpersonen keren de ochtend na de Rigiscan™-beoordeling terug naar het onderzoekscentrum en brengen het Rigiscan™-apparaat mee. De proefpersonen zullen die ochtend geen tanden poetsen of mondwater en/of andere ademverfrissers gebruiken. Er worden antropomorfe, bloeddruk- en hartslagopnamen gemaakt. Er wordt bloed afgenomen en opgeslagen. Urine wordt opgevangen en opgeslagen.

Volgorde twee:

Sequence Two is identiek aan Sequence One, behalve dat er dierlijke maaltijden worden verstrekt in plaats van plantaardige maaltijden. Voor proefpersonen die gerandomiseerd zijn naar maaltijden op basis van dieren in reeks één en reeks twee zullen identiek zijn, behalve dat er plantaardige maaltijden zullen worden verstrekt in plaats van maaltijden op basis van dieren.

Studietype

Ingrijpend

Inschrijving (Geschat)

46

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • New York
      • The Bronx, New York, Verenigde Staten, 10467
        • Werving
        • Montefiore Medical Center, Department of Medicine, Division of Cardiology
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

14 jaar tot 25 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusiecriteria:

  • Proefpersoon verstrekt schriftelijke geïnformeerde toestemming en HIPAA-autorisatie in het Engels voordat er onderzoeksprocedures worden uitgevoerd;
  • Geen medische therapie (behalve prn MDI's (doseerinhalatoren) en geen verandering in supplementen indien van toepassing)
  • IIEF-score hoger dan of gelijk aan 22
  • De proefpersoon heeft binnen 4 weken na inschrijving penis-vaginale seks gehad. De gebruikte IIEF-score wordt gevalideerd op basis van dit tijdvenster.
  • Man van 18-29 jaar oud
  • Woont op woon-werkafstand van Montefiore Health System
  • De partner van de proefpersoon (indien van toepassing) stemt ermee in de proefpersoon tijdens het onderzoek te ondersteunen
  • De proefpersoon stemt ermee in om alle tijdens de dieetinterventie geconsumeerde/dronken items te fotograferen en te delen
  • De proefpersoon stemt ermee in om alle illegale drugs, NSAID's en alcohol te vermijden gedurende ten minste twee dagen voorafgaand aan de Rigiscan™-opname en op de dagen en nachten van de Rigiscan™-opname
  • De proefpersoon stemt ermee in zich te onthouden van seksuele activiteit gedurende ten minste 36 uur voorafgaand aan de Rigiscan™-plaatsing en om geen seksuele activiteit te hebben op de dagen en nachten van de Rigiscan™-opname.
  • Onderwerp stemt ermee in om gedurende ten minste 36 uur voorafgaand aan de dagen en nachten van Rigiscan™-opname en op de dagen en nachten van Rigiscan™-opname geen erotisch of pornografisch materiaal te bekijken, te lezen of anderszins te consumeren
  • Onderwerp stemt ermee in om naar Montefiore te komen om Rigiscan™-training te volgen
  • De proefpersoon stemt ermee in om alleen toegestaan ​​voedsel/dranken te consumeren/drinken.
  • De proefpersoon stemt ermee in om alle persoonlijke bezoeken aan Montefiore bij te wonen, om de avond voor elk bezoek om 23.00 uur te beginnen met vasten en om alle bloedafnames/speekseltests/andere testen te ondergaan.
  • De proefpersoon stemt ermee in om tijdens de gehele duur van het onderzoek geen mondwater of mondspoelingen te gebruiken of opzettelijk te spugen. Proefpersonen wordt gevraagd om ten minste 2 dagen voorafgaand aan de inschrijving geen mondwater te gebruiken. Proefpersoon stemt ermee in om zijn tanden niet te poetsen op de ochtend van de dag van elk studiebezoek. Tandenpoetsen is overigens wel toegestaan.
  • BMI Minder dan 30, BMI groter dan of gelijk aan 18,5, gewicht groter dan 110 lbs.
  • Proefpersoon stemt ermee in zich te houden aan de studieprocedures en bezoeken.
  • Onderwerpoefeningen gedurende minimaal 15 minuten, minimaal twee keer per week. De proefpersoon stemt ermee in om de dag vóór en de dag van de Rigiscan™-metingen niet te sporten

Uitsluitingscriteria:

  • Relevante dieetallergie
  • Vegetarisch of veganistisch voedingspatroon
  • Geschiedenis van een eetstoornis; bewijs van voedselverslaving
  • Hypertensie en of voorgeschiedenis van hypertensie met of zonder medische behandeling
  • BMI hoger dan of gelijk aan 30, BMI lager dan 18,5 of gewicht lager dan of gelijk aan 110 lbs
  • Andere bekende chronische medische aandoeningen dan niet-inflammatoire musculoskeletale aandoeningen en astma
  • Geschiedenis van nierziekte of hyperkaliëmie
  • De proefpersoon heeft binnen 30 dagen voorafgaand aan de ondertekening van de toestemming een onderzoeksgeneesmiddel gekregen
  • Erectiestoornissen
  • Heeft een aandoening (bijv. psychiatrische ziekte) of situatie die, naar de mening van de onderzoeker, de onderzoeksresultaten kan verwarren of aanzienlijk kan interfereren met het vermogen van de patiënt om zich aan de onderzoeksprocedures te houden
  • Momenteel onder behandeling voor de ziekte van Peyronie
  • Abnormaal niveau van testosteron of schildklierstimulerend hormoon
  • Behandeld hypogonadisme of hypothyreoïdie
  • Geplande reizen tijdens de studie
  • Geschiedenis van middelenmisbruik in de afgelopen 12 maanden
  • Illegaal drugsgebruik, roken of vapen binnen 4 weken
  • Bovenste luchtwegaandoening binnen twee weken na screening
  • Als beroep oproepbaar is, geen nachtelijke of wachtdiensten tijdens de studie
  • Elke overdraagbare huid- of geslachtsziekte. Onderwerp meldt huiduitslag of laesies op de penis of het omliggende gebied. De proefpersoon zal worden gevraagd: "Heeft u huiduitslag of laesie op uw penis of omgeving?"

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Plantaardige arm
De plantaardige arm bestaat uit 3 bezoeken aan het klinisch onderzoekscentrum, het volgen van een plantaardig dieet en het gebruik van het Rigiscan™-apparaat om de frequentie, stijfheid en duur van nachtelijke erecties te meten.
Het eten wordt verzorgd door Montefiore-Einstein Food Services
Actieve vergelijker: Op dieren gebaseerde arm
De op dieren gebaseerde arm bestaat uit 3 bezoeken aan het klinisch onderzoekscentrum, het volgen van een op dieren gebaseerd dieet en het gebruik van het Rigiscan™-apparaat om de frequentie, stijfheid en duur van nachtelijke erecties te meten.
Het eten wordt verzorgd door Montefiore-Einstein Food Services

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal.
Tijdsspanne: 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™
Tijdsspanne: 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™
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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™
Tijdsspanne: 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™
Tijdsspanne: 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™
Tijdsspanne: 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™
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Robert Ostfeld, MD, Montefiore Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 oktober 2023

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

27 maart 2020

Eerst ingediend dat voldeed aan de QC-criteria

15 april 2020

Eerst geplaatst (Werkelijk)

16 april 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren