Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 60
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
80 (estimated)
Sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
Who this trial is looking for
This trial is looking for adults aged 40 to 60 with high blood pressure or prediabetes. Participants will take 150mg of MegaNatural BP grape seed extract daily and undergo health assessments related to blood pressure and heart health.
Are You a Good Fit for This Trial?
Must not be takingBlood pressure medicationsAnti-diabetes medicationsAnti-inflammatory medications
Rules you outDiabetesKidney diseaseHeart diseaseLiver diseaseGastrointestinal diseaseMetabolic diseaseRespiratory disease
You may be able to join if
I am between 40 and 60 years old.
I have high blood pressure between 120-140 systolic and under 90 diastolic.
I have a BMI under 30.
My fasting blood glucose is between 100-125 mg/dL.
I can give my informed consent.
I can follow dietary restrictions and complete study procedures.
I usually maintain my physical activity.
I can avoid alcohol and vigorous exercise 24 hours before visits.
You may not be able to join if
I am pregnant or planning to become pregnant.
I have diabetes or serious health conditions like heart disease.
I have had major surgery or trauma in the last 2 months.
I have recently used antibiotics or had a colonoscopy.
I have a history of eating disorders diagnosed by a professional.
I have abused substances in the last 2 years.
I consume more than 4 cups of coffee or tea daily.
I have an unstable weight change of 5 kg in the last 2 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 hear…
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.
Trial Locations
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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 o…
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
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