Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT05892328
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Actively losing weight/ trying to lose weight (unstable body weight fluctuations of \> 11 lbs in 3 months)
* Addicted to drugs or alcohol
* Have significant psychiatric or neurological disturbances that may interfere with the ability to follow the study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05892328
Study Brief:
Protocol Section:
NCT05892328