NCT06588218招募中不适用
Effect of Daily Fresh Watermelon Consumption on Gut and Cardiometabolic Health in Young Adults With Overweight and Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Gut Microbiome Diversity
研究概览
简要总结
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:
- 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?
- 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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Change in Gut Microbiome Diversity
时间窗: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Change in Oral Microbiome Diversity
时间窗: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.
次要结局
- Change in Gut Transit Time(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Arterial Stiffness(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Endothelial Function(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Ambulatory Blood Pressure(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Waist and Hip Circumference(Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Body Composition(Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Habitual Dietary Intake(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Biomarkers of Inflammation(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Biomarkers of Appetite(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Biomarkers of Intestinal Barrier Function(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Biomarkers of Cardiometabolic Health(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Recent Dietary Intake(Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Body Weight(Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
- Change in Body Mass Index(Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).)
研究者
Ravi Nagpal
PI
Florida State University
研究点 (2)
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