RECRUITING

MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

Quick Facts

Study Start:2024-08-08

Study Completion:2025-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06555952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Indika Edirisinghe

CONTACT

708-563-8178

iedirisi@iit.edu

Principal Investigator

Britt Burton-Freeman

PRINCIPAL_INVESTIGATOR

708-563-8276

Study Locations (Sites)

Clinical Nutrition Research Center

Chicago, Illinois, 60616

United States

Collaborators and Investigators

Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology

Britt Burton-Freeman, PRINCIPAL_INVESTIGATOR, 708-563-8276

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08

Study Completion Date2025-05-22

Study Record Updates

Study Start Date2024-08-08

Study Completion Date2025-05-22

Terms related to this study

Additional Relevant MeSH Terms

Hypertension
Pre Diabetes