Clinical Nutrition Research Center, Illinois Institute of Technology
Phase
Not applicable
Started
2024-08-08
Last updated
2026-08-28
Condition(s) studied
HypertensionPre Diabetes
Investigational drug(s) / intervention(s)
MegaNatural-BP SR 150Mg TabletPlacebo Capsule
MegaNatural-BP SR 150Mg Tablet: GSE MegaNatural BP
Placebo Capsule: given in place of GSE MegaNatural BP
Study summary
Inflammation and stressors can interfere with the function of the lining of blood vessels and insulin activity, therefore, investigators are aiming to see how the Grape seed Extract (GSE) called MegaNatural BP can help with limiting the effects of these factors. This research will study the effects of taking 150mg of MegaNatural BP GSE per day on blood pressure levels along with influences on heart health through assessing the function of the blood vessel lining and levels of inflammation.
Eligibility
Sex
ALL
Min age
40 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 40-60 years of age
* BMI \< 30kg/m2
* elevated blood pressure 120-140 mmHg (systolic) / \<90 mmHg (diastolic) at screening visit
* Has fasting blood glucose concentration between 100-125 mg/dL or HbA1c 5.7-6.4%.
* Not taking any medications that would interfere with outcomes of the study, i.e. blood pressure lowering medications or anti-diabetes medications.
* Able to provide informed consent
* Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study foods, records of food diary and GI tolerance questionnaire, sample collection procedures and study visit schedule)
* Able to maintain usual physical activity pattern
* Able to avoid / abstain from alcohol and vigorous physical activity for 24 hours prior to and during study visit
Exclusion Criteria:
* Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions
* Men and women with diabetes or have documented liver, kidney, cardiac, gastrointestinal, metabolic or respiratory diseases.
* Men and women with documented physical or mental disease/condition or major surgery as revealed by history or physical examination, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.
* 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; This may include anti-inflammatory medication (ibuprofen, Aleve/naproxen, aspirin, etc.)
* Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI.
* Has used antibiotics within the previous 2 months
* Had colonoscopy within 3 months
* 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 (\> 4 cups/d)
* Donated blood within last 3 months
* Men and women who do excessive exercise regularly or are an athlete
* Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
* Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
* Unusual working hours i.e., working overnight (e.g. 3rd shift)
* Follows a vegan diet or any extreme dietary patterns
Primary outcome measure(s)
Difference in change of systolic blood pressure — 6 weeks After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change
Difference in change of diastolic blood pressure — 6 weeks After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change
Trial sites (1)
Facility
City
Region
Status
Clinical Nutrition Research Center
Chicago
Illinois
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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