Effect of Watermelon on Gut and Cardiometabolic Health

Last updated: November 26, 2024
Sponsor: Florida State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Belvita Breakfast Sandwich + 12 oz Water

Watermelon

Clinical Study ID

NCT06588218
STUDY00005203
  • Ages 18-30
  • All Genders

Study 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

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

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, orE-cigarette products

  • Cardiovascular disease (will not exclude for hypertension), gastrointestinal disease (ulcerative colitis, celiac, Crohn's disease, diverticulosis, peptic ulcers, smallintestinal bacterial overgrowth, short bowel syndrome), neurological (multiplesclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroiddisorders, 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 toaffect nitric oxide synthesis (beet root juice or any beet supplement, Pycnogenol /Pine bark extract)

  • Known to be currently pregnant (self-disclosed)

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Belvita Breakfast Sandwich + 12 oz Water
Phase:
Study Start date:
October 13, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Florida State University - Gut Biome Lab

    Tallahassee, Florida 32306
    United States

    Active - Recruiting

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