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

Last updated: December 3, 2024
Sponsor: RDC Clinical Pty Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Maltodextrin

Grape Seed Extract

Clinical Study ID

NCT06440252
ALVCIR
  • Ages > 25
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 80-89mmHg)

  • Agree to not change current diet and/or exercise frequency or intensity duringentire study period

  • Agree to not participate in another clinical trial while enrolled in this trial

Exclusion

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 1month

  • 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 orother anticoagulation therapy, or substrates of P-glycoprotein including (but notlimited to) calcium channel blockers, cyclosporin, digoxin, erythromycin andprotease inhibitors(1).

  • Have a serious illness(2) e.g. mood disorders such as bipolar disorder, neurologicaldisorders 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 excludesnon-melanoma (e.g. BCC and SCC) skin cancers not requiring radiation orchemotherapy)

  • 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 participantunsuitable for inclusion

  • Participated in another trial in the past 1 month

  1. Any participant that begins taking antiplatelet medication during the trialwill be excluded from the study

  2. A serious illness is a condition that carries a risk of mortality, negativelyimpacts quality of life and daily function and/or is burdensome in symptomsand/or treatments.

  3. An unstable illness is any illness that is currently not being treated with astable dose of medication or is fluctuating in severity.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Maltodextrin
Phase: 3
Study Start date:
October 31, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • RDC Clinical Pty Ltd

    Brisbane, Queensland 4006
    Australia

    Active - Recruiting

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