MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

NCT06555952 | Recruiting

• 1 other identifier: 2024_081
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Difference in change of systolic blood pressure

  After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change

  6 weeks

• Difference in change of diastolic blood pressure

  After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change

  6 weeks

Secondary Outcomes (6)

• Change in vessel flexibility

  6 weeks

• Change in fasting and postprandial glucose

  6 weeks

• Change in fasting and postprandial insulin

  6 weeks

• Change in inflammatory marker C-reactive protein

  6 weeks

• Change in the ratio of arginine:ADMA

  6 weeks

Study Arms (2)

GSE Capsule

EXPERIMENTAL

150mg Grapeseed Extract MegaNatural BP

Dietary Supplement: MegaNatural-BP SR 150Mg Tablet

Placebo Capsule

PLACEBO COMPARATOR

Placebo supplement in place of GSE capsule

Other: Placebo Capsule

Interventions

MegaNatural-BP SR 150Mg Tablet DIETARY_SUPPLEMENT

GSE MegaNatural BP

GSE Capsule

Placebo Capsule OTHER

given in place of GSE MegaNatural BP

Placebo Capsule

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Glucose Intolerance

Interventions

Tablets

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Britt Burton-Freeman

  708-563-8276

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indika Edirisinghe

CONTACT

708-563-8178; iedirisi@iit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blinded, 2-arm parallel, 6-week study

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)