The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study

ALVCIR

This is a randomized, double-blind, placebo-controlled, 2 arm crossover study conducted over 11 weeks, with participants randomised to a product for 4 weeks, followed by a 3-week washout period before completing the second product for 4 weeks, to study the effectiveness of a grape seed extract on circulatory measures in healthy adults.

2024-06-30

2025-03-31

2025-06-30

Not yet recruiting

Early phase I

150

Inclusion Criteria: * Adults 25 years or older * Generally healthy * BMI 18 - 35kg/m2 * Able to provide informed consent * Have prehypertensive blood pressure (systolic 120-139 mmHg and/or diastolic 80-89 mmHg) * Agree to not change current diet and/or exercise frequency or intensity during entire study period * Agree to not participate in another clinical trial while enrolled in this trial Exclusion Criteria: * Those with a history of myocardial infarction, angina or bleeding disorders * Those who have uncontrolled thyroid diseases * Currently taking dietary supplements for circulation (e.g. fatty acids, CoQ10, L-arginine, red ginseng, ginseng, natto, ginkgo) or use of these in the last 1 month * Currently taking inflammation or circulatory associated medications (e.g. Pentoxifylline and vasodilators like nitroglycerin) or use of these in the last 1 month * Currently taking statins medication including atorvastatin (e.g. Lipitor, Lorstat), fluvastatin (e.g. Lescol or Vastin), pravastatin (e.g. Pravachol, Cholstat), rosuvastatin (e.g. Cavstat, Crestor) or simvastatin (e,g, Lipex, Zocor, Zimstat). * Currently taking Coumadin, Marevan (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy, or substrates of P-glycoprotein including (but not limited to) calcium channel blockers, cyclosporin, digoxin, erythromycin and protease inhibitors(1). * Have a serious illness(2) e.g. mood disorders such as bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions * Have an unstable illness(3) (i.e., changing medication/treatment) * Malignancy or treatment for malignancy within the previous 2 years (this excludes non-melanoma (e.g. BCC and SCC) skin cancers not requiring radiation or chemotherapy) * Active smokers, nicotine use or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>14 alcoholic drinks week) * Allergic to any of the ingredients in active or placebo formula * Pregnant or lactating woman or women trying to conceive * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * Participated in another trial in the past 1 month 1. Any participant that begins taking antiplatelet medication during the trial will be excluded from the study 2. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. 3. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-06-03