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

Circulatory; Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440252
• Other study ID #: ALVCIR
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: RDC Clinical Pty Ltd
• Contact: Amanda Rao, PhD
• Phone: +61 414 488 559
• Email: amanda[@]rdcglobal.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Circulatory; Change

Intervention

Drug:
• Grape Seed Extract
One daily dose of 1 capsule containing 600mg grape seed extract
• Maltodextrin
One daily dose of 1 capsule

Locations

Country	Name	City	State
Australia	RDC Clinical Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diastolic blood pressure (arm)	Change in Diastolic blood pressure (arm) as measured by blood pressure machine	Baseline, week 4, week 8, week 11
Secondary	Change in Systolic blood pressure (arm)	Change in Systolic blood pressure (arm) as measured by blood pressure machine	Baseline, week 4, week 8, week 11
Secondary	Change in Peripheral systolic and diastolic blood pressure (leg)	Change in Peripheral systolic and diastolic blood pressure (leg) as measured by blood pressure machine	Baseline, week 4, week 8, week 11
Secondary	Change in HGB	Change in HGB as measured by FBC via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in WBC	Change in WBC as measured by FBC via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in RBC	Change in RBC as measured by FBC via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in Platelet Aggregation	Change in Platelet Aggregation as measured by FBC via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in (endothelial nitric oxide synthase) eNOS	Change in eNOS as measured via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in endogenous nitric oxide (NO)	Change in NO as measured via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in Tibial artery structure	Change in Tibial artery structure via Laser Doppler Flowmetry	Baseline, week 4, week 8, week 11
Secondary	Change in blood flow of the right leg	Change in blood flow of the right leg via Laser Doppler Flowmetry	Baseline, week 4, week 8, week 11
Secondary	Change in oxygen saturation	Change in oxygen saturation as measured by pulse oximeter	Baseline, week 4, week 8, week 11
Secondary	Change in resting pulse rate	Change in resting pulse rate as digital blood pressure and resting pulse rate machine	Baseline, week 4, week 8, week 11
Secondary	Change in weight	Change in weight as measure by digital scales	Baseline, week 4, week 8, week 11
Secondary	Change in Body Mass Index (BMI)	Change in BMI as measured by weight and height calculation	Baseline, week 4, week 8, week 11
Secondary	Change in waist and hip circumference	Change in waist and hip circumference as measured by tape measure	Baseline, week 4, week 8, week 11
Secondary	Change in 36-Item Short Form Health Survey (SF-36)	Change in 36-Item Short Form Health Survey (SF-36) as self-reported	Baseline, week 4, week 8, week 11
Secondary	Change in E/LFT	Change in E/LFT as measured via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in triglycerides	Change in triglycerides as measured via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in cholesterol	Change in cholesterol as measured via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in blood glucose	Change in blood glucose as measured via blood test	Baseline, week 4, week 8, week 11
Secondary	Change in adverse events	Change in adverse events as reported by participant	Baseline, week 4, week 8, week 11