Меню
Идёт набор NCT06252922

Diet-Induced Changes in GEnetic Material

— Наблюдательное Diet, Healthy Body Weight Metabolic Disturbance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Diet, Healthy, Body Weight, Metabolic Disturbance. Базовые параметры: 20 лет — 35 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes

Обзор

This is a pilot study in 10 men to test the hypothesis that perturbations in substrate flux and the circulating metabolic and pro-inflammatory milieus during a high-fat diet paradigm will modulate DNA methylation of genes in sperm associated with obesity and cardiometabolic dysfunction.

Подробное описание

The Paternal Origins of Health and Disease (POHaD) hypothesis was introduced to emphasize the need for research on paternal transmission of environmental exposures on offspring disease development. Paternal exposure to an obesogenic diet has been shown to imprint epigenetic predisposition to metabolic diseases which can be evident in offspring for up to 5 generations. In support, observational studies in men show that high-fat diets and diets high in processed foods significantly reduced the quantity and quality of sperm, including motility, morphology, and concentration, and DNA methylation of genes associated with obesity and cardiometabolic dysfunction. Yet, there are no experimental diet manipulation studies in males to understand the contribution of an acute obesogenic diet (i.e., high-fat) on DNA methylation of genes associated with obesity and cardiometabolic diseases in male gametes.

The research aims of this study are to: 1) measure DNA methylation of genes in semen in response to a healthy and high-fat diet, 2) examine metabolic flexibility in response to a healthy and high fat diet and its contribution to DNA methylation in semen, and 3) examine the metabolic and inflammatory milieu in response to a healthy and high fat diet and its contribution to DNA methylation in semen. To achieve these aims, we will conduct a cross-sectional, observational study in 10 healthy male participants 20-35 years of age using two diets (Healthy Diet: 27% Fat, 55% Carbohydrate, 15% Protein followed by a High-Fat Diet: 50% Fat, 35% Carbohydrate, 15% Protein).

Первичные конечные точки

  • Sperm DNA methylation [Срок оценки: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet]
Вторичные конечные точки (1)
  • Sperm DNA Damage [Срок оценки: Baseline, Immediately after the healthy diet, Immediately after the high-fat diet]

Критерии участия

Критерии включения

  • Male based on biological sex
  • Age 20-35 years
  • BMI between 18.5 and 24.9 kg/m2
  • White/Caucasian
  • Willing to consume pre-prepared meals
  • Willing to wear an accelerometer and continuous glucose monitor (CGM)
  • Willing to track diet intake
  • Willing to stay 24 hours, including overnight in a research clinic
  • Willing to provide blood and sperm samples
  • Willing to consent to whole-genome sequencing of DNA

Критерии исключения

  • Unstable weight in the last 3 months (±5% weight loss or gain)
  • Shift work or working in a factory setting
  • Habitual smoking or use of tobacco products, including vaping, within the past 6 months.
  • History of clinically diagnosed diabetes
  • Hypertension (>140/90 mmHg measured at screening)
  • Has undergone bariatric surgery
  • History of cardiovascular disease, neurological disease, or other chronic diseases, including cancer
  • History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
  • Adherence to special or restrained diets (e.g., low-CHO, low-fat, or vegetarian/vegan diets) or food allergies associated with study foods.
  • Currently engaging in >150 minutes moderate-intensity or >75 minutes of vigorous-intensity physical activity each week
  • Drinking more than 14 servings of beer or alcohol per week
  • Depressive (Score ≥10), anxiety (Score ≥8), and stress (Score≥15) symptomology (Score ≥16) from the 42-item Depression, Anxiety, Stress Scales (DASS)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-кроссовер

Центры проведения

США · 1 центр
  • Pennington Biomedical Research Center — Baton Rouge

Идентификаторы

NCT: NCT06252922 · PBRC 2023-043

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗