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

RDC Clinical Pty Ltd1 site in 1 country35 target enrollmentOctober 31, 2024

ConditionsCirculatory; Change

InterventionsGrape Seed Extract Maltodextrin

DrugsGrape Seed Extract Maltodextrin

Overview

Phase: Phase 3
Intervention: Grape Seed Extract
Conditions: Circulatory; Change
Sponsor: RDC Clinical Pty Ltd
Enrollment: 35
Locations: 1
Primary Endpoint: Change in Diastolic blood pressure (arm)
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 31, 2024

End Date

December 31, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

RDC Clinical Pty Ltd

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Grape Seed Extract

Grape seed extract 600mg per day - 1 capsule per day

Intervention: Grape Seed Extract

Maltodextrin

Maltodextrin - 1 capsule per day

Intervention: Maltodextrin

Outcomes

Primary Outcomes

Change in Diastolic blood pressure (arm)

Time Frame: Baseline, week 4, week 8, week 11

Change in Diastolic blood pressure (arm) as measured by blood pressure machine

Secondary Outcomes

Change in Peripheral systolic and diastolic blood pressure (leg)(Baseline, week 4, week 8, week 11)
Change in HGB(Baseline, week 4, week 8, week 11)
Change in WBC(Baseline, week 4, week 8, week 11)
Change in RBC(Baseline, week 4, week 8, week 11)
Change in Platelet Aggregation(Baseline, week 4, week 8, week 11)
Change in Systolic blood pressure (arm)(Baseline, week 4, week 8, week 11)
Change in (endothelial nitric oxide synthase) eNOS(Baseline, week 4, week 8, week 11)
Change in endogenous nitric oxide (NO)(Baseline, week 4, week 8, week 11)
Change in Tibial artery structure(Baseline, week 4, week 8, week 11)
Change in triglycerides(Baseline, week 4, week 8, week 11)
Change in blood flow of the right leg(Baseline, week 4, week 8, week 11)
Change in oxygen saturation(Baseline, week 4, week 8, week 11)
Change in resting pulse rate(Baseline, week 4, week 8, week 11)
Change in weight(Baseline, week 4, week 8, week 11)
Change in Body Mass Index (BMI)(Baseline, week 4, week 8, week 11)
Change in waist and hip circumference(Baseline, week 4, week 8, week 11)
Change in 36-Item Short Form Health Survey (SF-36)(Baseline, week 4, week 8, week 11)
Change in E/LFT(Baseline, week 4, week 8, week 11)
Change in cholesterol(Baseline, week 4, week 8, week 11)
Change in blood glucose(Baseline, week 4, week 8, week 11)
Change in adverse events(Baseline, week 4, week 8, week 11)