Bioavailability and Pharmacokinetic Parameters of Watermelon (Rind, Flesh and Seeds) Polyphenols

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy Subjects

In brief

The primary objectives of the study are outlined below: 1. To investigate the relative bioavailability and absorption/kinetic profile of polyphenols after consumption of watermelon rind, flesh and seeds, respectively in an acute pilot study. 2. To study the effects of watermelon intake on endothelial function using the FMD technique and to understand the relationship between plasma metabolites, including L-citrulline and arginine, and FMD responses.

Key facts

Study ID

NCT03365960

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

6

Starts

2018-01-15

Expected to finish

2019-04-02

Last updated by the study team

2020-07-14

Who can join

Age: 20 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• • Men or women, 20-45 years of age with body mass index (BMI) in range from 27.5-32 kg/m2
• Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2 years)
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
• Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements especially arginine and L-citrulline, etc.
• Able to provide informed consent
• Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food diary and questionnaire, and study visit schedule)

You may not qualify if…

• • Men and women who smoke
• Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
• Men and women who consume > 2 servings of watermelons per day
• Men and women known to have/diagnosed with diabetes mellitus
• Men and women who have fasting blood glucose concentrations > 125 mg/dL
• Men and women who have uncontrolled blood pressure >140 mmHg (systolic)/90 mmHg (diastolic)
• Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
• Men and women with cancer other than non-melanoma skin cancer in previous 5 years
• Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study
• Women who are lactating
• Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
• Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
• Men and women who are vegans or vegetarian
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
• Substance (alcohol or drug) abuse within the last 2 years
• Excessive coffee and tea consumers (> 5 cups/d)
• Men and women who do excessive exercise regularly or an athlete
• Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
• Women who are taking unstable dose of hormonal contraceptives and/or stable dose for less than 6 months
• Unusual working hours i.e., working overnight (e.g. 3rd shift)

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.