MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in change of systolic blood pressure;Difference in change of diastolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Change in vessel flexibility;Change in fasting and postprandial glucose;Change in fasting and postprandial insulin;Change in inflammatory marker C-reactive protein;Change in the ratio of arginine:ADMA;Change in GSE metabolites profiles

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