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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gut Transit Time | Evaluate changes in gut transit time after watermelon or control snack consumption from baseline to final analysis, using a blue-dye capsule. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Arterial Stiffness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ravinder Nagpal, PhD | Contact | 850-644-1829 | rnagpal@fsu.edu | |
| Cole Patoine, M.S | Contact | cjp23a@fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ravinder Nagpal, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University - Gut Biome Lab | Recruiting | Tallahassee | Florida | 32306 | United States |
Deidentified IPD will not be retain past three years, at the time of this submission the researchers does not plan to make IPD available
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| 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 |
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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 |
| Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Endothelial Function | 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. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Ambulatory Blood Pressure | 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. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Waist and Hip Circumference | Evaluate changes in waist and hip circumference (centimeters), as well as waist-hip ratio at each study visit before, after and during watermelon consumption. | Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Body Composition | 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. | Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Habitual Dietary Intake | Assess changes in habitual dietary intake via 3-day food logs, analyzed using nutrient analysis software. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Biomarkers of Inflammation | 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. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Biomarkers of Appetite | 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. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Biomarkers of Intestinal Barrier Function | 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. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Biomarkers of Cardiometabolic Health | 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. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Recent Dietary Intake | Assess changes in dietary intake via 24 hr recalls, analyzed using nutrient analysis software. | Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Body Weight | Evaluate changes in body weight (kg) at each study visit before, after and during watermelon consumption. | Screening, Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| Change in Body Mass Index | Evaluate changes in Body Mass Index (kg/m2) before, during and after consumption of watermelon. | Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16). |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |