Effect of Watermelon on Gut and Cardiometabolic Health

NCT06588218 | Recruiting

• 1 other identifier: STUDY00005203
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Dysbiosis; Obesity and Overweight

Keywords

Gut Microbiome; Dysbiosis; Diet; Overweight; Obesity; Watermelon; Lycopene; Citrulline; Metagenomic; vascular

Outcome Measures

Primary Outcomes (2)

• Change in Gut Microbiome Diversity

  Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.

  Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).

• Change in Oral Microbiome Diversity

  Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.

  Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).

Secondary Outcomes (14)

• Change in Gut Transit Time

  Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).

• Change in Arterial Stiffness

  Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).

• Change in Endothelial Function

  Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).

• Change in Ambulatory Blood Pressure

  Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).

• Change in Waist and Hip Circumference

  Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).

Study Arms (2)

Watermelon Condition

EXPERIMENTAL

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

Other: Watermelon

Control Condition

ACTIVE COMPARATOR

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

Other: Belvita Breakfast Sandwich + 12 oz Water

Interventions

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

Also known as: Whole Watermelon, Diced Watermelon

Watermelon Condition

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

Also known as: Isocaloric Snack, Breakfast Sandwich, Control Snack

Control Condition

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University - Gut Biome Lab

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Dysbiosis

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Ravinder Nagpal, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ravinder Nagpal, PhD

CONTACT

850-644-1829; rnagpal@fsu.edu

Cole Patoine, M.S

CONTACT

cjp23a@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: October 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)