MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors
Clinical Nutrition Research Center, Illinois Institute of Technology · NCT06555952
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40–60 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 80
- US sites recruiting
- 1
- Study start
- August 8, 2024
- Record last updated
- August 28, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: MegaNatural-BP SR 150Mg Tablet; Placebo Capsule
Conditions: Hypertension; Pre Diabetes
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Clinical Nutrition Research Center
Chicago, IL 60616
Site contact: freemanstudies · 312-567-5300 · freemanstudies@iit.edu
Study contacts (from the official record)
- Indika Edirisinghe · 708-563-8178 · iedirisi@iit.edu
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