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Effekten av kostholdsmønster på erektil funksjon (ERECTION)

22. juli 2026 oppdatert av: Montefiore Medical Center

Virkningen av et plantebasert kosthold versus et dyrebasert kosthold på erektil funksjon hos friske menn med normal erektil funksjon: Ereksjonsstudien

Målet med denne studien er å finne ut om erektil funksjon påvirkes av kostholdsmønstre hos friske menn med normal erektil funksjon.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Besøk 1:

Etter å ha gjennomgått og signert samtykke, vil emnene bli undersøkt. Screeningen vil bestå av:

Fullfør IIEF (International Index of Erectile Function) og et spørreskjema for matfrekvens.

Registrer sykehistorie, medisiner Mål høyde og vekt Vitals Ta blod for totalt testosteron, kjønnshormonbidende globulin og TSH (thyreoideastimulerende hormon) Personer vil bli spurt om tilstedeværelsen av kjønnsutslett eller lesjoner

Hvis IIEF-skåren er unormal, vil forsøkspersonene bli bedt om å kontakte PCP (primærpleier).

Forsøkspersonene vil bli kontaktet med laboratorietestresultater. Hvis unormalt, vil pasienten bli bedt om å kontakte PCP.

Hvis forsøkspersonen ikke har PCP, vil kontaktinformasjon for en PCP bli gitt. Emner som oppfyller inklusjons- og eksklusjonskriterier vil bli randomisert til enten sekvens én eller sekvens to. Når forsøkspersonene først er påmeldt, vil ikke forsøkspersonene endre kostvaner gjennom hele studiens varighet, annet enn i løpet av de to kveldene og de to hele dagene når det tilbys mat (se nedenfor).

Sekvens én:

Besøk 2:

Forsøkspersonene returnerer til studiesenteret om morgenen etter å ha fastet (annet enn å ha drukket vann) siden kl. 23.00 kvelden før. Personer vil ikke pusse tennene eller bruke munnvann og/eller andre pustfriskere den morgenen. Antropomorfe registreringer, blodtrykk og hjertefrekvens vil bli gjort. Blod vil bli tappet og lagret. Urin vil bli samlet og lagret. Fagene vil bli undervist i hvordan de bruker Rigiscan™-enheten. Forsøkspersonene vil motta én plantebasert middag. Forsøkspersonene vil deretter forlate studiesenteret og spise vanlig diett frem til kl. 17.00. Resten av kvelden frem til kl. 23.00 vil deltakerne kun spise middagen. Vann vil være den eneste tillatte drikken etter kl. Middagen bør inntas kl. 20.30, EST (Eastern Standard Time). Forsøkspersonene vil sende bilder av alt som konsumeres (spise eller drikke) etter kl. 17.00 til PI eller til en studierepresentant, et medlem av studieteamet vil ha tekst- eller verbalkontakt med forsøkspersonen minst én gang samme kveld. Forsøkspersonene vil faste annet enn vann etter kl. 23.00. Den kvelden vil forsøkspersonene gjøre en Rigiscan™-vurdering over natten hjemme. Tiden motivet legger seg og tiden motivet våkner for dagen bør registreres. Forsøkspersonen godtar å være i seng med Rigiscan™ på (annet enn for nødstilfeller eller nødvendige turer på badet) i minst syv timer.

Besøk 3:

Forsøkspersonene returnerer til studiesenteret morgenen etter Rigiscan™-vurderingen og tar med Rigiscan™-enheten. Forsøkspersonene vil ha fastet annet enn å drikke vann siden klokken 23.00 kvelden før. Personer vil ikke pusse tenner eller bruke munnvann og/eller andre pustefriskere den morgenen. Antropomorfe registreringer, blodtrykk og hjertefrekvens vil bli gjort. Blod vil bli tappet og lagret. Urin vil bli samlet og lagret. Forsøkspersonene vil deretter motta en hel dag med plantebaserte måltider. Forsøkspersonene vil bli oppfordret til å spise frokost på studiesenteret etter at de første antropomorfe tiltakene er gjort, blod er tappet og urin er samlet. Forsøkspersonene vil tekste bilder av alt som blir konsumert i løpet av den dagen til PI og/eller til en studierepresentant, og et medlem av studieteamet vil ha tekst eller verbal kontakt med forsøkspersonen minst to ganger i løpet av den dagen. Middagen bør inntas klokken 20.30, EST. Forsøkspersonene vil faste annet enn vann etter kl. 23.00. Den kvelden vil forsøkspersonene gjøre en Rigiscan™-vurdering over natten hjemme. Svart kaffe og/eller te er kun tillatt før kl. Tiden motivet legger seg og tiden motivet våkner for dagen bør registreres. Forsøkspersonen godtar å være i seng med Rigiscan™ på (annet enn for nødstilfeller eller nødvendige turer på badet) i minst syv timer.

Besøk 4:

Forsøkspersonene returnerer til studiesenteret morgenen etter Rigiscan™-vurderingen og tar med Rigiscan™-enheten. Forsøkspersonene vil ikke pusse tenner eller bruke munnvann og/eller andre pustefriskere den morgenen. Antropomorfe registreringer, blodtrykk og hjertefrekvens vil bli gjort. Blod vil bli tappet og lagret. Urin vil bli samlet og lagret. Det vil da være en utvaskingsperiode på 8-12 dager og forsøkspersonene vil bli instruert om å gå tilbake til vanlige kostholdsvaner i løpet av denne utvaskingsperioden.

Besøk 5:

Etter utvaskingsperioden returnerer forsøkspersonene til studiesenteret om morgenen etter å ha fastet (annet enn å ha konsumert vann) siden kl. 23.00 kvelden før. Personer vil ikke pusse tenner eller bruke munnvann og/eller andre pustefriskere den morgenen. Antropomorfe registreringer, blodtrykk og hjertefrekvens vil bli gjort. Blod vil bli tappet og lagret. Urin vil bli samlet og lagret. Forsøkspersonene vil motta én dyrebasert middag. Forsøkspersonene vil deretter forlate studiesenteret og spise vanlig diett frem til kl. 17.00. Resten av kvelden frem til kl. 23.00 vil deltakerne kun spise middagen. Vann vil være den eneste drikken som konsumeres etter kl. Middagen bør inntas klokken 20.30, EST. Forsøkspersonene vil sende bilder av alt som konsumeres (spise eller drikke) etter kl. 17.00 til PI eller til en studierepresentant, og et medlem av studieteamet vil ha tekst- eller verbalkontakt med forsøkspersonen minst én gang samme kveld. Forsøkspersonene vil faste annet enn vann etter kl. 23.00. Den kvelden vil forsøkspersonene gjøre en Rigiscan™-vurdering over natten hjemme. Tiden motivet legger seg og tiden motivet våkner for dagen bør registreres. Forsøkspersonen godtar å være i seng med Rigiscan™ på (annet enn for nødstilfeller eller nødvendige turer på badet) i minst syv timer.

Besøk 6:

Forsøkspersonene returnerer til studiesenteret morgenen etter Rigiscan™-vurderingen og tar med Rigiscan™-enheten. Personer vil ikke pusse tenner eller bruke munnvann og/eller andre pustefriskere den morgenen. Antropomorfe, blodtrykks- og EndoPAT™-registreringer vil bli gjort. Spytt vil bli lagret. Blod vil bli tappet og lagret. Forsøkspersonene vil da motta en hel dag med dyrebaserte måltider. Forsøkspersonene vil bli oppfordret til å spise frokost på studiesenteret etter at de første antropomorfe tiltakene er gjort, spytt er oppnådd og blod er tappet. Forsøkspersonene vil tekste bilder av alt som blir konsumert i løpet av den dagen til PI og/eller til en studierepresentant, og studieteamet vil ha tekst eller verbal kontakt med forsøkspersonen minst to ganger i løpet av den dagen. Middagen bør inntas klokken 20.30, EST. Forsøkspersonene vil faste annet enn vann etter kl. 23.00. Den kvelden vil forsøkspersonene gjøre en Rigiscan™-vurdering over natten hjemme. Svart kaffe og/eller te er kun tillatt før kl. Tiden motivet legger seg og tiden motivet våkner for dagen bør registreres. Forsøkspersonen godtar å være i seng med Rigiscan™ på (annet enn for nødstilfeller eller nødvendige turer på badet) i minst syv timer.

Besøk 7 (studieslutt):

Forsøkspersonene returnerer til studiesenteret morgenen etter Rigiscan™-vurderingen og tar med Rigiscan™-enheten. Forsøkspersonene vil ikke pusse tenner eller bruke munnvann og/eller andre pustefriskere den morgenen. Antropomorfe registreringer, blodtrykk og hjertefrekvens vil bli gjort. Blod vil bli tappet og lagret. Urin vil bli samlet og lagret.

Sekvens to:

Sekvens to er identisk med sekvens én, bortsett fra at dyrebaserte måltider tilbys i stedet for plantebaserte måltider. For forsøkspersoner som er randomisert til dyrebaserte måltider i sekvens en og sekvens to vil være identiske, bortsett fra at plantebaserte måltider vil bli gitt i stedet for dyrebaserte måltider.

Studietype

Intervensjonell

Registrering (Antatt)

46

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • New York
      • The Bronx, New York, Forente stater, 10467
        • Rekruttering
        • Montefiore Medical Center, Department of Medicine, Division of Cardiology
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 25 år (Voksen)

Tar imot friske frivillige

Ja

Beskrivelse

Inklusjonskriterier:

  • Emnet gir skriftlig informert samtykke og HIPAA-autorisasjon på engelsk før noen studieprosedyrer utføres;
  • Ingen medisinsk behandling (annet enn prn MDIs (målt dose inhalatorer) og ingen endring i kosttilskudd hvis aktuelt)
  • IIEF-score større eller lik 22
  • Personen vil ha hatt penis-vaginal sex innen 4 uker etter registrering. IIEF-poengsummen som brukes er validert basert på dette tidsvinduet.
  • Mann i alderen 18-29 år
  • Bor i pendleravstand fra Montefiore Health System
  • Emnets signifikante andre (hvis aktuelt) samtykker i å støtte emnet under studien
  • Forsøkspersonen godtar å fotografere og dele alle ting som konsumeres/drikkes under kosttilskuddet
  • Forsøkspersonen samtykker i å unngå alle ulovlige stoffer, NSAIDs og alkohol i minst to dager før Rigiscan™-opptak og på dagene og nettene med Rigiscan™-opptak
  • Subjektet godtar å avstå fra seksuell aktivitet i minst 36 timer før Rigiscan™-plassering og å ikke ha seksuell aktivitet på dagene og nettene med Rigiscan™-opptaket.
  • Subjektet godtar å ikke se, lese eller på annen måte konsumere erotisk eller pornografisk materiale i minst 36 timer før dagene og nettene til Rigiscan™-opptaket og på dagene og nettene med Rigiscan™-opptaket
  • Subjektet samtykker i å komme til Montefiore for å gjennomgå Rigiscan™-opplæring
  • Emnet godtar å kun innta/drikke tillatt mat/drikke.
  • Forsøkspersonen godtar å delta på alle personlige besøk på Montefiore, å begynne å faste kl. 23.00 kvelden før hvert besøk, og å gjennomgå alle blodprøver/spytt/andre tester.
  • Forsøkspersonen samtykker i å ikke bruke munnvann eller munnskylling eller med vilje spyttet under hele varigheten av studien. Forsøkspersonene vil bli bedt om å avstå fra å bruke munnvann i minst 2 dager før påmelding. Forsøkspersonen samtykker i å ikke pusse tennene om morgenen dagen for hvert studiebesøk. Tannpuss er ellers tillatt.
  • BMI mindre enn 30, BMI større eller lik 18,5, vekt større enn 110 lbs.
  • Emnet godtar å overholde studieprosedyrene og besøkene.
  • Fagøvelser i minst 15 minutter minst to ganger i uken. Forsøkspersonen samtykker i å unngå trening dagen før og dagen for Rigiscan™-målingene

Ekskluderingskriterier:

  • Relevant kostholdsallergi
  • Vegetarisk eller vegansk kostholdsmønster
  • Historie om en spiseforstyrrelse; bevis på matavhengighet
  • Hypertensjon og eller historie med hypertensjon med eller uten medisinsk behandling
  • BMI større eller lik 30, BMI mindre enn 18,5, eller vekt mindre enn eller lik 110lbs
  • Kjent kronisk medisinsk sykdom annet enn ikke-inflammatorisk muskel- og skjelettsykdom og astma
  • Historie med nyresykdom eller hyperkalemi
  • Forsøkspersonen har mottatt et forsøkslegemiddel innen 30 dager før samtykke ble underskrevet
  • Erektil dysfunksjon
  • Har en tilstand (f.eks. psykiatrisk sykdom) eller situasjon som, etter etterforskerens mening, kan forvirre studieresultatene, eller kan forstyrre pasientens evne til å følge studieprosedyrene betydelig.
  • Gjennomgår for tiden behandling for Peyronies sykdom
  • Unormalt nivå av testosteron eller skjoldbruskkjertelstimulerende hormon
  • Behandlet hypogonadisme eller hypotyreose
  • Planlagt reise under studiet
  • Historie om rusmisbruk de siste 12 månedene
  • Ulovlig narkotikabruk, røyking eller vaping innen 4 uker
  • Øvre luftveier innen to uker ved screening
  • Dersom yrket krever vakthold, ingen overnatting eller vakt under studiet
  • Enhver smittsom hud- eller kjønnssykdom. Personen rapporterer utslett eller lesjoner på penis eller området rundt. Emnet vil bli spurt: "har du utslett eller lesjon på penis eller området rundt?"

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Plantebasert arm
Den plantebaserte armen består av 3 besøk til det kliniske forskningssenteret, etter et plantebasert kosthold og bruk av Rigiscan™-enheten for å måle frekvensen, stivheten og varigheten av nattlige ereksjoner.
Annen: Plantebasert kosthold
Maten vil bli levert av Montefiore-Einstein Food Services
Aktiv komparator: Dyrebasert arm
Den dyrebaserte armen består av 3 besøk til det kliniske forskningssenteret, følger en dyrebasert diett og bruker Rigiscan™-enheten for å måle frekvensen, stivheten og varigheten av nattlige ereksjoner.
Annen: Dyrebasert diett
Maten vil bli levert av Montefiore-Einstein Food Services

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal.
Tidsramme: 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™
Tidsramme: 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™
Tidsramme: 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).

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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™
Tidsramme: 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™
Tidsramme: 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™
Tidsramme: 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™
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Montefiore Medical Center

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Robert Ostfeld, MD, Montefiore Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. oktober 2023

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

27. mars 2020

Først innsendt som oppfylte QC-kriteriene

15. april 2020

Først lagt ut (Faktiske)

16. april 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2019-10465

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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