Circulatory; Change
Conditions
Brief 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.
Interventions
One daily dose of 1 capsule containing 600mg grape seed extract
DRUGMaltodextrin
One daily dose of 1 capsule
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diastolic blood pressure (arm) | Baseline, week 4, week 8, week 11 | Change in Diastolic blood pressure (arm) as measured by blood pressure machine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cholesterol | Baseline, week 4, week 8, week 11 | Change in cholesterol as measured via blood test |
| Change in blood glucose | Baseline, week 4, week 8, week 11 | Change in blood glucose as measured via blood test |
| Change in 36-Item Short Form Health Survey (SF-36) | Baseline, week 4, week 8, week 11 | Change in 36-Item Short Form Health Survey (SF-36) as self-reported |
| Change in E/LFT | Baseline, week 4, week 8, week 11 | Change in E/LFT as measured via blood test |
| Change in Systolic blood pressure (arm) | Baseline, week 4, week 8, week 11 | Change in Systolic blood pressure (arm) as measured by blood pressure machine |
| Change in Peripheral systolic and diastolic blood pressure (leg) | Baseline, week 4, week 8, week 11 | Change in Peripheral systolic and diastolic blood pressure (leg) as measured by blood pressure machine |
| Change in HGB | Baseline, week 4, week 8, week 11 | Change in HGB as measured by FBC via blood test |
| Change in WBC | Baseline, week 4, week 8, week 11 | Change in WBC as measured by FBC via blood test |
| Change in RBC | Baseline, week 4, week 8, week 11 | Change in RBC as measured by FBC via blood test |
| Change in Platelet Aggregation | Baseline, week 4, week 8, week 11 | Change in Platelet Aggregation as measured by FBC via blood test |
| Change in (endothelial nitric oxide synthase) eNOS | Baseline, week 4, week 8, week 11 | Change in eNOS as measured via blood test |
| Change in endogenous nitric oxide (NO) | Baseline, week 4, week 8, week 11 | Change in NO as measured via blood test |
| Change in Tibial artery structure | Baseline, week 4, week 8, week 11 | Change in Tibial artery structure via Laser Doppler Flowmetry |
| Change in blood flow of the right leg | Baseline, week 4, week 8, week 11 | Change in blood flow of the right leg via Laser Doppler Flowmetry |
| Change in oxygen saturation | Baseline, week 4, week 8, week 11 | Change in oxygen saturation as measured by pulse oximeter |
| Change in resting pulse rate | Baseline, week 4, week 8, week 11 | Change in resting pulse rate as digital blood pressure and resting pulse rate machine |
| Change in weight | Baseline, week 4, week 8, week 11 | Change in weight as measure by digital scales |
| Change in Body Mass Index (BMI) | Baseline, week 4, week 8, week 11 | Change in BMI as measured by weight and height calculation |
| Change in waist and hip circumference | Baseline, week 4, week 8, week 11 | Change in waist and hip circumference as measured by tape measure |
| Change in triglycerides | Baseline, week 4, week 8, week 11 | Change in triglycerides as measured via blood test |
| Change in adverse events | Baseline, week 4, week 8, week 11 | Change in adverse events as reported by participant |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORAmanda Rao, PhD
RDC Clinical Pty Ltd
Outcome results
None listed