Watermelon Dose Response Blood Pressure Study

NCT05892328 | Active Not Recruiting

• 1 other identifier: IRB-2023-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Primary outcome: To evaluate the dose response effects of watermelon flesh in regulating Blood Pressure (BP) in individuals with pre-hypertension.
2. 2.Secondary outcomes: To study the dose-response effects of watermelon flesh intake on cardio-metabolic risk factors including plasma metabolic markers, lipid profile and nitrate/nitrite levels in individuals with pre-hypertension.

Conditions

Pre-hypertension; Cardiovascular Diseases

Keywords

Watermelon; Blood pressure; Pre-hypertension

Outcome Measures

Primary Outcomes (1)

• To evaluate the change in the dose response effects of watermelon flesh in regulating BP in individuals with pre-hypertension.

  This objective will be accomplished by assessing the 24-h Ambulatory Blood Pressure Machine (ABPM) in individuals with pre-hypertension before and after 4 weeks of watermelon flesh intake. Two doses of watermelon flesh will be tested (1 and 2 cup servings) compared to control.

  Baseline to 4 weeks

Secondary Outcomes (5)

• To evaluate the change in lipid profile in individuals with pre-hypertension after consuming watermelon flesh.

  Baseline to 4 weeks

• To evaluate the change in plasma and urine nitrite/nitrate in individuals with pre-hypertension after consuming watermelon flesh.

  Baseline to 4 weeks

• To evaluate the change in glucose in individuals with pre-hypertension after consuming watermelon flesh.

  Baseline to 4 weeks

• To evaluate the change in insulin in individuals with pre-hypertension after consuming watermelon flesh.

  Baseline to 4 weeks

• To evaluate the changes in L-Citrulline, Arginine, and Asymmetric Dimethylarginine (ADMA) in individuals with pre-hypertension after consuming watermelon flesh, analyzed by mass spectrometry.

  Baseline to 4 weeks

Study Arms (3)

Control

PLACEBO COMPARATOR

Calorie-matched control beverage

Other: Control

Watermelon flesh Dose 1

ACTIVE COMPARATOR

1 cup watermelon flesh, \~152 g

Other: Watermelon Flesh Dose 1

Watermelon flesh Dose 2

ACTIVE COMPARATOR

2 cups watermelon flesh, \~304 g

Other: Watermelon Flesh Dose 2

Interventions

Watermelon Flesh Dose 1 OTHER

1 cup watermelon flesh, \~152g, 7 days/week over a 4-week period

Watermelon flesh Dose 1

Watermelon Flesh Dose 2 OTHER

2 cups watermelon flesh, \~304 g, 7 days/week over a 4-week period

Watermelon flesh Dose 2

Control OTHER

304g italian ice, 0 g watermelon, 7 days/week over a 4-week period

Control

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are nonsmokers
• Healthy overweight/ obese man or woman between 25 and 65 years of age
• Blood pressure 120-160 mmHg systolic or 80-100 mm/Hg diastolic at screening visit
• Fasting blood glucose concentration between 100 mg/dL and 125 mg/dL at screening visit (value range indicate prediabetes, by finger prick and/or venous blood sampling)
• Have no clinical evidence/history of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease

You may not qualify if:

• Smoker
• Vegetarian
• Men and women who have fasting blood glucose concentration \<100 or \>125 mg/dL at screening visit
• Uncontrolled blood pressure ≥140 mmHg (systolic)/ ≥ 90 mmHg (diastolic)
• Over the counter supplements (e.g. fiber supplements, probiotics and/or prebiotics, antioxidants, anti-inflammation)
• Dietary supplements like (garlic, fish oil), glutamine supplements, grape seed extract, L-citrulline/arginine
• Cholesterol-lowering medications, anticoagulants, blood pressure-lowering medications,) and/or taking prescription medications that may interfere with study procedures or endpoints (e.g. gastrointestinal medications, antibiotics) within the last 30 days
• Have cancer other than non-melanoma skin cancer in previous 5 years
• Taking unstable dose of hormonal contraceptive and/or a stable dose less than 6 months
• Planning to become pregnant, pregnant and/or breast-feeding
• Excessive exerciser or a trained athlete
• Drink excessive amount of coffee/tea (\> 5 cups per day)
• Donated blood within last 3 months
• Have allergies/intolerances to foods consumed in the study
• Currently eat \> 2 servings of watermelons per day

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• National Watermelon Promotion Board: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Prehypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Indika Edirisinghe, Ph.D.

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The proposed trial will be a randomized, 3 arm, placebo-controlled, parallel study design

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 7, 2023
• Study Start: April 7, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)