Clinical trial NCT06588218: Effect of Watermelon on Gut and Cardiometabolic Health
Official title: Effect of Daily Fresh Watermelon Consumption on Gut and Cardiometabolic Health in Young Adults with Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Dysbiosis
Keywords: Gut Microbiome
Dysbiosis
Diet
Overweight
Obesity
Watermelon
Lycopene
Citrulline
Metagenomic
vascular
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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?


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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 \&amp;amp;gt; 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)

Primary outcomes:
measure: Change in Gut Microbiome Diversity
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Oral Microbiome Diversity
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Secondary outcomes:
measure: Change in Gut Transit Time
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Arterial Stiffness
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Endothelial Function
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Ambulatory Blood Pressure
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Waist and Hip Circumference
timeFrame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Body Composition
timeFrame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Habitual Dietary Intake
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Biomarkers of Inflammation
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Biomarkers of Appetite
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Biomarkers of Intestinal Barrier Function
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Biomarkers of Cardiometabolic Health
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Recent Dietary Intake
timeFrame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Body Weight
timeFrame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
measure: Change in Body Mass Index
timeFrame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University - Gut Biome Lab
state: Florida
Study officials:
affiliation: Florida State University
name: Ravinder Nagpal, PhD
role: PRINCIPAL_INVESTIGATOR
References: