Status:

RECRUITING

Effect of Watermelon on Gut and Cardiometabolic Health

Lead Sponsor:

Florida State University

Conditions:

Obesity and Overweight

Dysbiosis

Eligibility:

All Genders

18-30 years

Phase:

NA

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 adul...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

October 13 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT06588218

Start Date

October 13 2024

End Date

August 1 2026

Last Update

October 15 2025

Active Locations (1)

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Florida State University - Gut Biome Lab

Tallahassee, Florida, United States, 32306