Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Circulatory; Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Grape Seed Extract

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

Group Type ACTIVE_COMPARATOR

Grape Seed Extract

Intervention Type DRUG

One daily dose of 1 capsule containing 600mg grape seed extract

Maltodextrin

Maltodextrin - 1 capsule per day

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DRUG

One daily dose of 1 capsule

Interventions

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Grape Seed Extract

One daily dose of 1 capsule containing 600mg grape seed extract

Intervention Type DRUG

Maltodextrin

One daily dose of 1 capsule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No