Effect of Watermelon on Gut and Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorFlorida State University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between 18 and 30 years old
Ability to speak and read in English
Overweight or Obese Class 1 and 2 (BMI ≥ 25 - 39.9 kg/m2)
Disqualifiers
Intake of antibiotics in the last 3 months
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%).
Trial design
Design model
Crossover
Treatments tested in this trial
Watermelon
Other intervention2.5 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 interventionBelvita breakfast sandwich; 115 kcals, 1.5g fiber, 4.5g fat, 0mg lycopene, 0mg vitamin C) as well as 12 ounces of water
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Watermelon ConditionExperimental treatment 1 intervention
Group B: Control ConditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gut Microbiome Diversity
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).2
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.
Time frame
Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).Secondary outcomes
1
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.
Time frame
Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).2
Change in Arterial Stiffness
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).3
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.
Time frame
Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).4
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.
Time frame
Baseline (day 0), Visit 2 (week 6), Visit 3 (week 10), Visit 4 (week 16).Sponsors and contacts
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Source ClinicalTrials.gov