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MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits, 2 visits, 1 visit, 5 visits
  • Time periods mentioned: 6 weeks, 2 weeks
  • Procedures mentioned: Ultrasound, Questionnaires, Interviews, Blood draws, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last for six weeks."
  • "These visits include a screening visit, two ambulatory blood pressure device fitting visits, and four study day visits throughout the six weeks."
  • "The flexibility of subject's blood vessels will be measured using an ultrasound technique."
  • "Based on the results of the blood sugar, questionnaires, measurements and evaluation of their health, the subject may meet the criteria and be invited to participate in the study."
  • "Self-Characteristics and Dietary Surveys: During this visit, participants will be asked to complete online surveys that cover usual gastrointestinal (GI) symptoms and a 24-hour food recall."
  • "Confirmation the subject is ready to go for their study day by interview/discussion with study staff 1."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

IL