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L'impact du régime alimentaire sur la fonction érectile (ERECTION)

22 juillet 2026 mis à jour par: Montefiore Medical Center

L'impact d'un régime à base de plantes par rapport à un régime à base d'animaux sur la fonction érectile chez les hommes en bonne santé ayant une fonction érectile normale : l'étude ERECTION

Le but de cette étude est de déterminer si la fonction érectile est affectée par les habitudes alimentaires chez les hommes en bonne santé ayant une fonction érectile normale.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

Visite 1 :

Après avoir examiné et signé le consentement, les sujets seront sélectionnés. Le dépistage consistera à :

Remplir IIEF (International Index of Erectile Function) et un questionnaire de fréquence alimentaire.

Enregistrer les antécédents médicaux, les médicaments Mesurer la taille et le poids Vitals Prélever du sang pour la testostérone totale, la globuline fixant les hormones sexuelles et la TSH (hormone stimulant la thyroïde) Les sujets seront interrogés sur la présence d'éruptions ou de lésions génitales

Si le score IIEF est anormal, il sera conseillé aux sujets de contacter le PCP (prestataire de soins primaires).

Les sujets seront contactés avec les résultats des tests de laboratoire. Si anormal, il sera conseillé au sujet de contacter le PCP.

Si le sujet n'a pas de PCP, les coordonnées d'un PCP seront fournies. Les sujets répondant aux critères d'inclusion et d'exclusion seront randomisés dans la séquence 1 ou la séquence 2. Une fois inscrits, les sujets ne modifieront pas leurs habitudes alimentaires pendant toute la durée de l'étude, sauf pendant les deux soirées et les deux journées complètes où la nourriture est fournie (voir ci-dessous).

Première séquence :

Visite 2 :

Les sujets retournent au centre d'étude le matin après avoir jeûné (hors consommation d'eau) depuis 23h la veille. Les sujets ne se brosseront pas les dents ou n'utiliseront pas de rince-bouche et/ou d'autres rafraîchisseurs d'haleine ce matin-là. Des enregistrements anthropomorphiques, de pression artérielle et de fréquence cardiaque seront effectués. Le sang sera prélevé et stocké. L'urine sera collectée et stockée. Les sujets apprendront à utiliser l'appareil Rigiscan™. Les sujets recevront un dîner à base de plantes. Les sujets quitteront ensuite le centre d'étude et consommeront le régime alimentaire habituel jusqu'à 17 heures. Pour le reste de la soirée jusqu'à 23h les sujets ne consommeront que le dîner prévu. L'eau sera la seule boisson autorisée après 17h00. Le dîner doit être consommé à 20 h 30, HNE (heure normale de l'Est). Les sujets enverront par SMS des images de tout ce qui est consommé (manger ou boire) après 17 h au PI ou à un représentant de l'étude. Un membre de l'équipe d'étude aura un contact textuel ou verbal avec le sujet au moins une fois dans la soirée. Les sujets jeûneront autre que l'eau après 23h. Cette nuit-là, les sujets effectueront une évaluation Rigiscan™ pendant la nuit à la maison. L'heure à laquelle le sujet se couche et l'heure à laquelle il se réveille pour la journée doivent être enregistrées. Le sujet accepte d'être au lit avec Rigiscan™ activé (autre que pour des déplacements d'urgence ou nécessaires à la salle de bain) pendant au moins sept heures.

Visite 3 :

Les sujets retournent au centre d'étude le matin après l'évaluation Rigiscan™ et apportent le dispositif Rigiscan™. Les sujets auront été à jeun autre que boire de l'eau depuis 23 heures la veille. Les sujets ne se brosseront pas les dents ou n'utiliseront pas de rince-bouche et/ou d'autres rafraîchisseurs d'haleine ce matin-là. Des enregistrements anthropomorphiques, de pression artérielle et de fréquence cardiaque seront effectués. Le sang sera prélevé et stocké. L'urine sera collectée et stockée. Les sujets recevront ensuite une journée complète de repas à base de plantes. Les sujets seront encouragés à prendre le petit-déjeuner au centre d'étude après que les mesures anthropomorphiques initiales auront été effectuées, que le sang aura été prélevé et que l'urine aura été collectée. Les sujets enverront par SMS des images de tout ce qui est consommé au cours de cette journée au PI et/ou à un représentant de l'étude et un membre de l'équipe d'étude aura un contact textuel ou verbal avec le sujet au moins deux fois au cours de cette journée. Le dîner doit être consommé à 20h30, HNE. Les sujets jeûneront autre que l'eau après 23h. Cette nuit-là, les sujets effectueront une évaluation Rigiscan™ pendant la nuit à la maison. Le café noir et/ou le thé sont autorisés uniquement avant midi. L'heure à laquelle le sujet se couche et l'heure à laquelle il se réveille pour la journée doivent être enregistrées. Le sujet accepte d'être au lit avec Rigiscan™ activé (autre que pour des déplacements d'urgence ou nécessaires à la salle de bain) pendant au moins sept heures.

Visite 4 :

Les sujets retournent au centre d'étude le matin après l'évaluation Rigiscan™ et apportent le dispositif Rigiscan™. Les sujets ne se brosseront pas les dents ou n'utiliseront pas de rince-bouche et/ou d'autres rafraîchisseurs d'haleine ce matin-là. Des enregistrements anthropomorphiques, de pression artérielle et de fréquence cardiaque seront effectués. Le sang sera prélevé et stocké. L'urine sera collectée et stockée. Il y aura ensuite une période de sevrage pendant 8 à 12 jours et les sujets seront invités à reprendre leurs habitudes alimentaires habituelles pendant cette période de sevrage.

Visite 5 :

Après la période de sevrage, les sujets retournent au centre d'étude le matin après avoir jeûné (autre que la consommation d'eau) depuis 23h la veille. Les sujets ne se brosseront pas les dents ou n'utiliseront pas de rince-bouche et/ou d'autres rafraîchisseurs d'haleine ce matin-là. Des enregistrements anthropomorphiques, de pression artérielle et de fréquence cardiaque seront effectués. Le sang sera prélevé et stocké. L'urine sera collectée et stockée. Les sujets recevront un dîner à base d'animaux. Les sujets quitteront ensuite le centre d'étude et consommeront le régime alimentaire habituel jusqu'à 17 heures. Pour le reste de la soirée jusqu'à 23h les sujets ne consommeront que le dîner prévu. L'eau sera la seule boisson consommée après 17h. Le dîner doit être consommé à 20h30, HNE. Les sujets enverront par SMS des images de tout ce qui est consommé (manger ou boire) après 17h au PI ou à un représentant de l'étude et un membre de l'équipe d'étude aura un contact textuel ou verbal avec le sujet au moins une fois dans la soirée. Les sujets jeûneront autre que l'eau après 23h. Cette nuit-là, les sujets effectueront une évaluation Rigiscan™ pendant la nuit à la maison. L'heure à laquelle le sujet se couche et l'heure à laquelle il se réveille pour la journée doivent être enregistrées. Le sujet accepte d'être au lit avec Rigiscan™ activé (autre que pour des déplacements d'urgence ou nécessaires à la salle de bain) pendant au moins sept heures.

Visite 6 :

Les sujets retournent au centre d'étude le matin après l'évaluation Rigiscan™ et apportent le dispositif Rigiscan™. Les sujets ne se brosseront pas les dents ou n'utiliseront pas de rince-bouche et/ou d'autres rafraîchisseurs d'haleine ce matin-là. Des enregistrements anthropomorphiques, de pression artérielle et EndoPAT™ seront effectués. La salive sera stockée. Le sang sera prélevé et stocké. Les sujets recevront ensuite une journée complète de repas à base d'animaux. Les sujets seront encouragés à prendre le petit-déjeuner au centre d'étude après que les mesures anthropomorphiques initiales auront été effectuées, que la salive aura été obtenue et que le sang aura été prélevé. Les sujets enverront par SMS des photos de tout ce qui est consommé au cours de cette journée au PI et/ou à un représentant de l'étude et l'équipe de l'étude aura un contact textuel ou verbal avec le sujet au moins deux fois au cours de cette journée. Le dîner doit être consommé à 20h30, HNE. Les sujets jeûneront autre que l'eau après 23h. Cette nuit-là, les sujets effectueront une évaluation Rigiscan™ pendant la nuit à la maison. Le café noir et/ou le thé sont autorisés uniquement avant midi. L'heure à laquelle le sujet se couche et l'heure à laquelle il se réveille pour la journée doivent être enregistrées. Le sujet accepte d'être au lit avec Rigiscan™ activé (autre que pour des déplacements d'urgence ou nécessaires à la salle de bain) pendant au moins sept heures.

Visite 7 (fin d'étude):

Les sujets retournent au centre d'étude le matin après l'évaluation Rigiscan™ et apportent le dispositif Rigiscan™. Les sujets ne se brosseront pas les dents ou n'utiliseront pas de rince-bouche et/ou d'autres rafraîchisseurs d'haleine ce matin-là. Des enregistrements anthropomorphiques, de pression artérielle et de fréquence cardiaque seront effectués. Le sang sera prélevé et stocké. L'urine sera collectée et stockée.

Deuxième séquence :

La deuxième séquence est identique à la séquence un, sauf que des repas à base d'animaux sont fournis au lieu de repas à base de plantes. Pour les sujets randomisés aux repas à base d'animaux dans la séquence un et la séquence deux seront identiques, sauf que des repas à base de plantes seront fournis à la place des repas à base d'animaux.

Type d'étude

Interventionnel

Inscription (Estimé)

46

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • New York
      • The Bronx, New York, États-Unis, 10467
        • Recrutement
        • Montefiore Medical Center, Department of Medicine, Division of Cardiology
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

14 ans à 25 ans (Adulte)

Accepte les volontaires sains

Oui

La description

Critère d'intégration:

  • Le sujet fournit un consentement éclairé écrit et une autorisation HIPAA en anglais avant que toute procédure d'étude ne soit menée ;
  • Aucun traitement médical (autre que les MDI prn (inhalateurs-doseurs) et aucun changement dans les suppléments, le cas échéant)
  • Score IIEF supérieur ou égal à 22
  • Le sujet aura eu des relations sexuelles péniennes-vaginales dans les 4 semaines suivant l'inscription. Le score IIEF utilisé est validé sur la base de cette fenêtre temporelle.
  • Homme âgé de 18 à 29 ans
  • Vit à distance de navettage du système de santé de Montefiore
  • L'autre significatif du sujet (le cas échéant) accepte de soutenir le sujet pendant l'étude
  • Le sujet accepte de photographier et de partager tous les articles consommés/bu pendant l'intervention diététique
  • Le sujet accepte d'éviter toutes les drogues illicites, les AINS et l'alcool pendant au moins deux jours avant l'enregistrement Rigiscan™ et les jours et nuits de l'enregistrement Rigiscan™
  • Le sujet accepte de s'abstenir de toute activité sexuelle pendant au moins 36 heures avant le placement du Rigiscan™ et de n'avoir aucune activité sexuelle les jours et les nuits de l'enregistrement du Rigiscan™.
  • Le sujet s'engage à ne pas visionner, lire ou autrement consommer du matériel érotique ou pornographique pendant au moins 36 heures avant les jours et nuits d'enregistrement Rigiscan™ et les jours et nuits d'enregistrement Rigiscan™
  • Le sujet accepte de venir à Montefiore pour suivre la formation Rigiscan™
  • Le sujet accepte de ne consommer/boire que des aliments/boissons autorisés.
  • Le sujet accepte d'assister à toutes les visites en personne à Montefiore, de commencer à jeûner à 23 heures la veille de chaque visite et de subir tous les prélèvements sanguins/salivaires/autres tests.
  • Le sujet s'engage à ne pas utiliser de rince-bouche ou de rince-bouche ni à cracher intentionnellement pendant toute la durée de l'étude. Les sujets seront invités à s'abstenir d'utiliser un rince-bouche pendant au moins 2 jours avant l'inscription. Le sujet s'engage à ne pas se brosser les dents le matin du jour de chaque visite d'étude. Le brossage des dents est par ailleurs autorisé.
  • IMC inférieur à 30, IMC supérieur ou égal à 18,5, poids supérieur à 110 lb.
  • Le sujet s'engage à se conformer aux procédures d'étude et aux visites.
  • Le sujet s'exerce pendant au moins 15 minutes au moins deux fois par semaine. Le sujet accepte d'éviter de faire de l'exercice la veille et le jour des mesures Rigiscan™

Critère d'exclusion:

  • Allergie alimentaire pertinente
  • Régime alimentaire végétarien ou végétalien
  • Antécédents d'un trouble de l'alimentation ; preuve de dépendance alimentaire
  • Hypertension et/ou antécédent d'hypertension avec ou sans traitement médical
  • IMC supérieur ou égal à 30, IMC inférieur à 18,5 ou poids inférieur ou égal à 110 lb
  • Maladie médicale chronique connue autre que les maladies musculo-squelettiques non inflammatoires et l'asthme
  • Antécédents de maladie rénale ou d'hyperkaliémie
  • Le sujet a reçu un médicament expérimental dans les 30 jours précédant la signature du consentement
  • Dysérection
  • A une condition (par exemple, une maladie psychiatrique) ou une situation qui, de l'avis de l'investigateur, peut confondre les résultats de l'étude, ou peut interférer de manière significative avec la capacité du patient à adhérer aux procédures de l'étude
  • Actuellement sous traitement pour la maladie de La Peyronie
  • Niveau anormal de testostérone ou d'hormone stimulant la thyroïde
  • Hypogonadisme ou hypothyroïdie traités
  • Voyage prévu pendant l'étude
  • Antécédents de toxicomanie au cours des 12 derniers mois
  • Consommation de drogues illicites, tabagisme ou vapotage dans les 4 semaines
  • Maladie des voies respiratoires supérieures dans les deux semaines suivant le dépistage
  • Si la profession nécessite d'être sur appel, pas de travail de nuit ou d'astreinte pendant l'étude
  • Toute maladie cutanée ou vénérienne transmissible. Le sujet signale une éruption cutanée ou des lésions sur le pénis ou la zone environnante. On demandera au sujet "Avez-vous une éruption cutanée ou une lésion sur votre pénis ou la zone environnante ?"

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Bras végétal
Le bras végétal consiste en 3 visites au centre de recherche clinique, suivant un régime à base de plantes et utilisant l'appareil Rigiscan™ pour mesurer la fréquence, la rigidité et la durée des érections nocturnes.
La nourriture sera fournie par Montefiore-Einstein Food Services
Comparateur actif: Bras d'origine animale
Le bras animal consiste en 3 visites au centre de recherche clinique, suivant un régime à base d'animaux et utilisant le dispositif Rigiscan™ pour mesurer la fréquence, la rigidité et la durée des érections nocturnes.
La nourriture sera fournie par Montefiore-Einstein Food Services

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent of time ≥60% erect during overnight Rigiscan™ use after 4 meals.
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percent of time ≥60% erect during overnight Rigiscan™ use after 1 meal.
Délai: 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™
Délai: 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™
Délai: 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).

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Heart rate
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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)
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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
Délai: Time zero (Visit 2), at ~24 hours after time zero (Visit 3), at ~48 hours after time zero (Visit 4), after 8-12 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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™
Délai: 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™
Délai: 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™
Délai: 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™
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Robert Ostfeld, MD, Montefiore Medical Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 octobre 2023

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

27 mars 2020

Première soumission répondant aux critères de contrôle qualité

15 avril 2020

Première publication (Réel)

16 avril 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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