Recruiting

MegaNatural BP® GSEMegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

Sponsor:

Clinical Nutrition Research Center, Illinois Institute of Technology

Code:

NCT06555952

Conditions

Hypertension

Pre Diabetes

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Not accepted

Interventions

MegaNatural-BP SR 150Mg Tablet

Placebo Capsule

Study Details

Brief 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.

Conditions

Hypertension

Pre Diabetes

Study ID

NCT06555952

Start date

Aug 8, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 22, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: GSE Capsule

150mg Grapeseed Extract MegaNatural BP

placebo comparator: Placebo Capsule

Placebo supplement in place of GSE capsule

Interventions

MegaNatural-BP SR 150Mg Tablet

GSE MegaNatural BP

Placebo Capsule

given in place of GSE MegaNatural BP

Primary outcome measure

Difference in change of systolic blood pressure [ Time Frame: 6 weeks ]
Difference in change of diastolic blood pressure [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Indika Edirisinghe

708-563-8178 iedirisi@iit.edu

Locations

Clinical Nutrition Research Center

Recruiting

Chicago, Illinois, United States, 60616

Contacts

freemanstudies

312-567-5300 freemanstudies@iit.edu

More Information

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Clinical Nutrition Research Center, Illinois Institute of Technology on 2026-08-28.