RECRUITING

Effect of Watermelon on Gut and Cardiometabolic Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Effect of Daily Fresh Watermelon Consumption on Gut and Cardiometabolic Health in Young Adults with Overweight and Obesity

Quick Facts

Study Start:2024-10-13
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06588218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 18 and 30 years old
  2. * Ability to speak and read in English
  3. * Overweight or Obese Class 1 and 2 (BMI ≥ 25 - 39.9 kg/m2)
  1. * Intake of antibiotics in the last 3 months
  2. * Intake of pre/pro/postbiotics in the last 3 months
  3. * Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products
  4. * 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%).
  5. * Food allergy to study foods
  6. * Any allergy to melon
  7. * Any allergy to the isocaloric snack (gluten)
  8. * Regular consumption of watermelon greater than 2 servings / week
  9. * Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women
  10. * Class 3 Obesity (BMI \> 40 kg/m2)
  11. * 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)
  12. * Known to be currently pregnant (self-disclosed)

Contacts and Locations

Study Contact

Ravinder Nagpal, PhD
CONTACT
850-644-1829
rnagpal@fsu.edu
Cole Patoine, M.S
CONTACT
cjp23a@fsu.edu

Principal Investigator

Ravinder Nagpal, PhD
PRINCIPAL_INVESTIGATOR
Florida State University

Study Locations (Sites)

Florida State University - Gut Biome Lab
Tallahassee, Florida, 32306
United States

Collaborators and Investigators

Sponsor: Florida State University

  • Ravinder Nagpal, PhD, PRINCIPAL_INVESTIGATOR, Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-13
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-10-13
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity and Overweight
  • Dysbiosis