Effects of Grape Seed Extract on Blood Pressure and Metabolic Health
MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors
This study is testing if taking a daily grape seed extract supplement can help people with high blood pressure and pre-diabetes improve their heart health and metabolism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Clinical Nutrition Research Center, Illinois Institute of Technology Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06555952 on ClinicalTrials.gov |
What this trial studies
This research investigates the impact of a daily supplement of MegaNatural BP, a grape seed extract, on blood pressure and cardiometabolic risk factors in individuals with elevated blood pressure and pre-diabetes. Participants will take 150mg of the extract daily over six weeks, with multiple visits to assess blood pressure, insulin activity, and blood vessel flexibility. The study aims to determine if this lower dosage can effectively improve cardiovascular health and metabolic function compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-60 with elevated blood pressure and pre-diabetes.
Not a fit: Patients currently on blood pressure or anti-diabetes medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural supplement option for managing blood pressure and improving metabolic health in at-risk individuals.
How similar studies have performed: Previous studies have shown that higher doses of grape seed extract can lower blood pressure, suggesting potential success for this lower dosage approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Clinical Nutrition Research Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Britt Burton-Freeman — 708-563-8276
- Study coordinator: Indika Edirisinghe
- Email: iedirisi@iit.edu
- Phone: 708-563-8178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.