Clinical trial NCT06440252: Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults
Official title: The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Circulatory; Change
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Diastolic blood pressure (arm)
timeFrame: Baseline, week 4, week 8, week 11
Secondary outcomes:
measure: Change in Systolic blood pressure (arm)
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in Peripheral systolic and diastolic blood pressure (leg)
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in HGB
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in WBC
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in RBC
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in Platelet Aggregation
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in (endothelial nitric oxide synthase) eNOS
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in endogenous nitric oxide (NO)
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in Tibial artery structure
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in blood flow of the right leg
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in oxygen saturation
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in resting pulse rate
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in weight
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in waist and hip circumference
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in E/LFT
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in triglycerides
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in cholesterol
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in blood glucose
timeFrame: Baseline, week 4, week 8, week 11
measure: Change in adverse events
timeFrame: Baseline, week 4, week 8, week 11
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: Amanda Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: