NCT Number: NCT06588218
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?
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
Location status: Recruiting
Andrea Lobene, PhD
SUB_INVESTIGATOR
Cole Patoine, MS
SUB_INVESTIGATOR
Jania Kadar
CONTACT
Joseph Watso, PhD
SUB_INVESTIGATOR
Ravinder Nagpal, PhD
PRINCIPAL_INVESTIGATOR
Saiful Singar, MS
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Whole Watermelon, Diced Watermelon
Belvita breakfast sandwich; 115 kcals, 1.5g fiber, 4.5g fat, 0mg lycopene, 0mg vitamin C) as well as 12 ounces of water
Other names: Isocaloric Snack, Breakfast Sandwich, Control Snack
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate changes in gut transit time after watermelon or control snack consumption from baseline to final analysis, using a blue-dye capsule.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate the effects of watermelon on arterial stiffness, determined by measuring Pulse Wave Analysis (PWA) and Pulse Wave Velocity (PWV). These are captured by the SphygmoCor XCEL System through the descending aorta to the femoral artery. The aortic pulse wave velocity is detected from carotid and femoral arterial pulses measured non-invasively and simultaneously
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate the effects of watermelon on macrovascular endothelial function, which will be evaluated using the flow-mediated dilation (FMD) technique using a Finapres device, which measures the arterial dilation response following acute occlusion of the brachial artery.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate the effect of watermelon on ambulatory blood pressure (systolic and diastolic), determined using a 12-hour ambulatory blood pressure monitor (TM-2440). The 12-hour ambulatory blood pressure monitor will collect blood pressure readings every 20 minutes during waking hours only.
Time frame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during watermelon consumption.
Time frame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate changes in body composition, including lean mass (kg), fat mass kg), and total body water (kg). This is assessed using a bioimpedance spectroscopy device (ImpediMed SBF7) at each study visit before, after and during watermelon consumption.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Relevant biomarkers are to be collected via venous blood samples to determine changes in inflammation, including but not limited to C-reactive protein (CRP), IL-1 (Interleukin-1), IL-1 beta, IL-6, IL-10, IL-17, IL-23, Tumor Necrosis Factor Alpha (TNF-a), Interferon-gamma (IFN-Y). All will be expressed in units of pg/mL.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Relevant biomarkers are to be collected via venous blood samples to determine changes in appetite including Insulin, Glucagon, glucagon-like peptide 1 (GLP-1), Adiponectin, Leptin, Ghrelin, and Peptide YY. All will be expressed in units of pg/mL.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Relevant biomarkers are to be collected via venous blood samples to determine changes in intestinal barrier function including LPS (lipopolysaccharides), LBP (lipopolysaccharide binding protein), CD14, Secretory IgA. All will be expressed in units of pg/mL.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Relevant biomarkers are to be collected via venous blood samples to determine changes in cardiometabolic health including HDL, LDL, total cholesterol, and triglycerides. All will be expressed in units of mg/dL.
Time frame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Assess changes in dietary intake via 24 hr recalls, analyzed using nutrient analysis software.
Time frame: Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate changes in body weight (kg) at each study visit before, after and during watermelon consumption.
Time frame: Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).
Evaluate changes in Body Mass Index (kg/m2) before, during and after consumption of watermelon.
Contact information is provided by the study sponsor or research team.
Cole Patoine, M.S
CONTACT
Ravinder Nagpal, PhD
CONTACT
Florida State University
Other
Effect of Daily Fresh Watermelon Consumption on Gut and Cardiometabolic Health in Young Adults With Overweight and Obesity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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