Status:
RECRUITING
MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Conditions:
Hypertension
Pre Diabetes
Eligibility:
All Genders
40-60 years
Phase:
NA
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 MegaN...
Detailed Description
This is a research study to determine if an extract made from grape seeds might help control blood pressure. Previous research studies have found that taking this extract as a daily supplement at 300 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06555952
Start Date
August 8 2024
End Date
December 31 2026
Last Update
July 15 2025
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616