Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2024-10-13
2026-08-31
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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
Watermelon
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
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
Belvita Breakfast Sandwich + 12 oz Water
Belvita breakfast sandwich; 115 kcals, 1.5g fiber, 4.5g fat, 0mg lycopene, 0mg vitamin C) as well as 12 ounces of water
Interventions
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Watermelon
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
Belvita breakfast sandwich; 115 kcals, 1.5g fiber, 4.5g fat, 0mg lycopene, 0mg vitamin C) as well as 12 ounces of water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to speak and read in English
* Overweight or Obese Class 1 and 2 (BMI ≥ 25 - 39.9 kg/m2)
Exclusion Criteria
* 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)
18 Years
30 Years
ALL
No
Sponsors
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Florida State University
OTHER
Responsible Party
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Ravi Nagpal
PI
Principal Investigators
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Ravinder Nagpal, PhD
Role: PRINCIPAL_INVESTIGATOR
Florida State University
Locations
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Florida State University - Gut Biome Lab
Tallahassee, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00005203
Identifier Type: -
Identifier Source: org_study_id
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