Меню
Идёт набор NCT06588218

Effect of Watermelon on Gut and Cardiometabolic Health

Без фазы С лечением Obesity and Overweight Dysbiosis

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
В протоколе указаны: Watermelon, Belvita Breakfast Sandwich + 12 oz Water.
Кому может быть актуально
Состояния в реестре: Obesity and Overweight, Dysbiosis. Базовые параметры: 18 лет — 30 лет · Все.
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

Effect of Daily Fresh Watermelon Consumption on Gut and Cardiometabolic Health in Young Adults With Overweight and Obesity

Обзор

The goal of this clinical trial is to evaluate the effect of daily fresh watermelon consumption for 6-weeks on gut health, including microbiome diversity, gut barrier and immune function in young adults with overweight and obesity. The main questions it aims to answer are: 1. Will consuming fresh watermelon daily for 6-weeks will improve intestinal barrier health and increase microbiome diversity such as an increased population of beneficial 'probiotic' bacteria when compared to control participants consuming a low-fat snack? 2. Will consuming fresh watermelon daily for six-weeks will improve other health measures, including body-composition, blood pressure, blood vessel function, blood lipid profiles, and measures of inflammation, as compared to control participants consuming a low-fat snack for the same time period?

Вмешательства

  • Другое Watermelon
    2.5 cups of whole fresh watermelon (\~375 grams, 115 kcals, 0.5g fat, 1.5g fiber, 17,225mcg lycopene, 30.75mg vitamin C) of fresh watermelon daily for six weeks
  • Другое Belvita Breakfast Sandwich + 12 oz Water
    Belvita breakfast sandwich; 115 kcals, 1.5g fiber, 4.5g fat, 0mg lycopene, 0mg vitamin C) as well as 12 ounces of water

Первичные конечные точки

  • Change in Gut Microbiome Diversity [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Oral Microbiome Diversity [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
Вторичные конечные точки (12)
  • Change in Gut Transit Time [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Arterial Stiffness [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Endothelial Function [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Ambulatory Blood Pressure [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Waist and Hip Circumference [Срок оценки: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Body Composition [Срок оценки: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Habitual Dietary Intake [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Biomarkers of Inflammation [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Biomarkers of Appetite [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Biomarkers of Intestinal Barrier Function [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Biomarkers of Cardiometabolic Health [Срок оценки: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]
  • Change in Recent Dietary Intake [Срок оценки: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).]

Критерии участия

Критерии включения

  • Between 18 and 30 years old
  • Ability to speak and read in English
  • Overweight or Obese Class 1 and 2 (BMI ≥ 25 - 39.9 kg/m2)

Критерии исключения

  • Intake of antibiotics in the last 3 months
  • Intake of pre/pro/postbiotics in the last 3 months
  • Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products
  • Cardiovascular disease (will not exclude for hypertension), gastrointestinal disease (ulcerative colitis, celiac, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C greater than 9%).
  • Food allergy to study foods
  • Any allergy to melon
  • Any allergy to the isocaloric snack (gluten)
  • Regular consumption of watermelon greater than 2 servings / week
  • Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women
  • Class 3 Obesity (BMI \> 40 kg/m2)
  • Current user of Citrulline, Arginine, Nitric Oxide or other supplements known to affect nitric oxide synthesis (beet root juice or any beet supplement, Pycnogenol / Pine bark extract)
  • Known to be currently pregnant (self-disclosed)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Florida State University - Gut Biome Lab — Tallahassee

Идентификаторы

NCT: NCT06588218 · STUDY00005203

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗