MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

Launched by CLINICAL NUTRITION RESEARCH CENTER, ILLINOIS INSTITUTE OF TECHNOLOGY · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called MegaNatural BP Grape Seed Extract, which is thought to help lower blood pressure and improve heart health. The researchers want to see if taking 150 mg of this supplement daily can reduce inflammation and support the inner lining of blood vessels in people who have elevated blood pressure and pre-diabetes.

To participate, you should be between 40 and 60 years old, have a body mass index (BMI) under 30, and have slightly high blood pressure (between 120-140 mmHg systolic) and blood sugar levels indicating pre-diabetes. You will need to avoid certain medications and supplements that could affect the study's results. Participants will keep a food diary, follow dietary guidelines, and will need to avoid alcohol and heavy exercise for a day before study visits. If you're interested and meet the criteria, this study could be a valuable opportunity to contribute to research on heart health and blood pressure management.

Gender

ALL

Eligibility 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