Clinical trial

Effect of Watermelon on Gut and Cardiometabolic Health

Recruiting now · Not applicable · 1 countries · Registry ID NCT06588218

Recruiting nowNot applicableInterventional

What this study is about

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?

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 30 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity and Overweight, Dysbiosis

Full registry 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 \> 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)

Treatments and study arms

Watermelon

Other

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

Belvita Breakfast Sandwich + 12 oz Water

Other

Belvita breakfast sandwich; 115 kcals, 1.5g fiber, 4.5g fat, 0mg lycopene, 0mg vitamin C) as well as 12 ounces of water

Primary outcomes

Change in Gut Microbiome DiversityBaseline (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 DiversityBaseline (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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Florida State University - Gut Biome Lab🇺🇸 Tallahassee, Florida, United States
Jania KadarContact
Ravinder Nagpal, PhDPrincipal Investigator
Cole Patoine, MSSub Investigator