Effect of Watermelon on Gut and Cardiometabolic Health

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT06588218
Status
Recruiting
Apply to this trial

Conditions

  • Dysbiosis
  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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?

Key Dates

Start date
Oct 13, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Watermelon Condition
    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
  • Active Comparator: Control Condition
    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

Primary Outcome Measure

Change in Gut Microbiome Diversity [ Time Frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State University - Gut Biome LabTallahasseeFlorida32306
Jania Kadar
[email protected]
+1-850-644-1828
Ravinder Nagpal, PhD (PRINCIPAL_INVESTIGATOR)
Cole Patoine, MS (SUB_INVESTIGATOR)
Saiful Singar, MS (SUB_INVESTIGATOR)
Andrea Lobene, PhD (SUB_INVESTIGATOR)
Joseph Watso, PhD (SUB_INVESTIGATOR)

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By research site
Florida State University - Gut Biome Lab· Tallahassee, FL

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