Effect of Watermelon on Gut and Cardiometabolic Health

Florida State University

Status: Enrolling

Conditions: Dysbiosis; Obesity and Overweight

Treatments: Other: Watermelon; Other: Belvita Breakfast Sandwich + 12 oz Water

Study type: Interventional

Funder types: Other

Identifiers

NCT06588218

STUDY00005203

Details and patient eligibility

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?

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Watermelon Condition

Experimental group

Description:

This group will maintain a normal diet supplemented with 2.5 cups (\~375 grams, 115 kcals, 0.5g fat, 1.5g fiber, 17,225mcg lycopene, 30.75mg vitamin C) of fresh watermelon daily for six weeks

Treatment:

Other: Watermelon

Control Condition

Active Comparator group

Description:

This group will maintain a normal diet supplemented with an isocaloric control snack (Belvita breakfast sandwich; 115 kcals, 1.5g fiber, 4.5g fat, 0mg lycopene, 0mg vitamin C) as well as 12 ounces of water

Treatment:

Other: Belvita Breakfast Sandwich + 12 oz Water