Grape seed extract's effects on circulation in healthy adults
The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study
This study is testing if grape seed extract can improve circulation in healthy adults who have slightly high blood pressure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT06440252 on ClinicalTrials.gov |
What this trial studies
This interventional study is a randomized, double-blind, placebo-controlled, 2-arm crossover trial that lasts for 11 weeks. Participants, aged 25 and older, will be assigned to receive either grape seed extract or a placebo for 4 weeks, followed by a 3-week washout period, and then switch to the other product for another 4 weeks. The study aims to evaluate the effectiveness of grape seed extract on various circulatory measures in generally healthy adults with prehypertensive blood pressure.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 25 years or older with prehypertensive blood pressure.
Not a fit: Patients with a history of cardiovascular issues or those currently taking specific circulatory-related medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into natural supplements for improving circulatory health in adults.
How similar studies have performed: While there is limited information on similar studies, the use of natural supplements for circulatory health has shown promise in some previous research.
Eligibility criteria
Show full inclusion / exclusion 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 * 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.
Where this trial is running
Brisbane, Queensland
- RDC Clinical Pty Ltd — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: Amanda Rao, PhD — RDC Clinical Pty Ltd
- Study coordinator: Amanda Rao, PhD
- Email: amanda@rdcglobal.com.au
- Phone: +61 414 488 559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.