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

NCT03365960 | Completed

• 1 other identifier: IRB2017-078
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of the study are outlined below:

1. 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. 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.

Conditions

Healthy Subjects

Keywords

Watermelon; Watermelon phytochemicals bioavailability; Flow Mediated Vasodilation; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Quantitative characterization of watermelon polyphenolic compounds in plasma over 24-hour in humans

  This will be conducted by using ultra-high performance liquid chromatography iFunnel quadrupole time of flight mass spectrometer (UHPLC-QTOF-MS) and triple quadrupole mass spectrometer (UHPLC-QQQ-MS).

  24-hour Postprandial period

Secondary Outcomes (2)

• The changes in endothelial function using ultrasound technique after consumption of each treatment

  24-hour Postprandial period

• the relationship between plasma metabolites and FMD responses after consumption of treatments

  24-hour Postprandial period

Study Arms (4)

Active1

ACTIVE COMPARATOR

watermelon rind

Dietary Supplement: Watermelon Rind

Active2

ACTIVE COMPARATOR

watermelon flesh

Dietary Supplement: Watermelon Flesh

Active3

ACTIVE COMPARATOR

watermelon seeds

Dietary Supplement: Watermelon Seeds

Control Comparator

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

Watermelon Rind DIETARY_SUPPLEMENT

watermelon rind

Active1

Watermelon Flesh DIETARY_SUPPLEMENT

watermelon flesh

Active2

Watermelon Seeds DIETARY_SUPPLEMENT

watermelon seeds

Active3

Placebo DIETARY_SUPPLEMENT

Control Comparator

Control Comparator

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 8, 2017
• Study Start: January 15, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 2, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)