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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grape Seed Extract | Active Comparator | Grape seed extract 600mg per day - 1 capsule per day |
|
| Maltodextrin | Placebo Comparator | Maltodextrin - 1 capsule per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grape Seed Extract | Drug | One daily dose of 1 capsule containing 600mg grape seed extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Peripheral systolic and diastolic blood pressure (leg) |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Rao, PhD | RDC Clinical Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| D056604 | Grape Seed Extract |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Maltodextrin | Drug | One daily dose of 1 capsule |
|
Change in Peripheral systolic and diastolic blood pressure (leg) as measured by blood pressure machine
| Baseline, week 4, week 8, week 11 |
| Change in HGB | Change in HGB as measured by FBC via blood test | Baseline, week 4, week 8, week 11 |
| Change in WBC | Change in WBC as measured by FBC via blood test | Baseline, week 4, week 8, week 11 |
| Change in RBC | Change in RBC as measured by FBC via blood test | Baseline, week 4, week 8, week 11 |
| Change in Platelet Aggregation | Change in Platelet Aggregation as measured by FBC via blood test | Baseline, week 4, week 8, week 11 |
| Change in (endothelial nitric oxide synthase) eNOS | Change in eNOS as measured via blood test | Baseline, week 4, week 8, week 11 |
| Change in endogenous nitric oxide (NO) | Change in NO as measured via blood test | Baseline, week 4, week 8, week 11 |
| Change in Tibial artery structure | Change in Tibial artery structure via Laser Doppler Flowmetry | Baseline, week 4, week 8, week 11 |
| 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 |
| Change in oxygen saturation | Change in oxygen saturation as measured by pulse oximeter | Baseline, week 4, week 8, week 11 |
| 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 |
| Change in weight | Change in weight as measure by digital scales | Baseline, week 4, week 8, week 11 |
| Change in Body Mass Index (BMI) | Change in BMI as measured by weight and height calculation | Baseline, week 4, week 8, week 11 |
| Change in waist and hip circumference | Change in waist and hip circumference as measured by tape measure | Baseline, week 4, week 8, week 11 |
| 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 |
| Change in E/LFT | Change in E/LFT as measured via blood test | Baseline, week 4, week 8, week 11 |
| Change in triglycerides | Change in triglycerides as measured via blood test | Baseline, week 4, week 8, week 11 |
| Change in cholesterol | Change in cholesterol as measured via blood test | Baseline, week 4, week 8, week 11 |
| Change in blood glucose | Change in blood glucose as measured via blood test | Baseline, week 4, week 8, week 11 |
| Change in adverse events | Change in adverse events as reported by participant | Baseline, week 4, week 8, week 11 |
| D004364 |
| Pharmaceutical Preparations |