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Watermelon for High Blood Pressure (WMBP Trial)
N/A
Waitlist Available
Led By Indika Edirisinghe, Ph.D.
Research Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Men and women who have fasting blood glucose concentration <100 or >125 mg/dL at screening visit
Have cancer other than non-melanoma skin cancer in previous 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Summary
This trial studies how watermelon can help regulate blood pressure in people with pre-hypertension and its effects on other health factors.
Who is the study for?
This trial is for healthy overweight/obese adults aged 25-65 with slightly elevated blood pressure but no history of serious health issues. Participants should be nonsmokers, not on a vegetarian diet, and have stable weight without plans to lose more. They shouldn't consume certain supplements or medications that affect blood pressure or metabolism.
What is being tested?
The study tests how different amounts of watermelon flesh impact blood pressure in people with pre-hypertension. It also looks at the effects on heart-related risk factors like cholesterol and metabolic markers. Participants will receive one of two doses of watermelon flesh or a control treatment.
What are the potential side effects?
Since the intervention involves consuming watermelon, side effects are expected to be minimal but may include food-related allergies or intolerances for those sensitive to ingredients in the study's diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fasting blood sugar is between 100 and 125 mg/dL, indicating prediabetes.
Select...
I have no history of major organ or metabolic diseases.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My fasting blood sugar is either below 100 or above 125 mg/dL.
Select...
I have not had any cancer except for non-melanoma skin cancer in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the change in the dose response effects of watermelon flesh in regulating BP in individuals with pre-hypertension.
Secondary study objectives
To evaluate the change in glucose in individuals with pre-hypertension after consuming watermelon flesh.
To evaluate the change in insulin in individuals with pre-hypertension after consuming watermelon flesh.
To evaluate the change in lipid profile in individuals with pre-hypertension after consuming watermelon flesh.
+2 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Watermelon flesh Dose 1Active Control1 Intervention
1 cup watermelon flesh, \~152 g
Group II: Watermelon flesh Dose 2Active Control1 Intervention
2 cups watermelon flesh, \~304 g
Group III: ControlPlacebo Group1 Intervention
Calorie-matched control beverage
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Who is running the clinical trial?
Clinical Nutrition Research Center, Illinois Institute of TechnologyLead Sponsor
54 Previous Clinical Trials
2,964 Total Patients Enrolled
National Watermelon Promotion BoardOTHER
1 Previous Clinical Trials
23 Total Patients Enrolled
Indika Edirisinghe, Ph.D.Principal InvestigatorIllinois Institute of Technology
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My fasting blood sugar is between 100 and 125 mg/dL, indicating prediabetes.Your blood pressure is not well controlled and is too high.Your blood pressure is between 120-160 over 80-100 at the screening visit.You have given blood in the last 3 months.I have no history of major organ or metabolic diseases.You drink a lot of coffee or tea, more than 5 cups per day.You are actively trying to lose weight or have had big changes in your weight in the past 3 months.I am an overweight/obese adult between 25 and 65 years old.I am currently taking over-the-counter supplements like fiber, probiotics, or antioxidants.I have been on a stable dose of hormonal contraceptive for less than 6 months.You exercise a lot or are a professional athlete.I haven't taken any medications in the last 30 days that could affect the study.Currently eating more than two servings of watermelon per day.You are allergic or intolerant to the foods that will be eaten during the study.You have a problem with using drugs or drinking alcohol.People who do not smoke.You smoke cigarettes.You are a vegetarian.My fasting blood sugar is either below 100 or above 125 mg/dL.I am not taking supplements like garlic, fish oil, glutamine, grape seed extract, or L-citrulline/arginine.I have not had any cancer except for non-melanoma skin cancer in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Watermelon flesh Dose 1
- Group 3: Watermelon flesh Dose 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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