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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06440252




Registration number
NCT06440252
Ethics application status
Date submitted
17/05/2024
Date registered
3/06/2024
Date last updated
18/10/2024

Titles & IDs
Public title
Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults
Scientific title
The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study
Secondary ID [1] 0 0
ALVCIR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Circulatory; Change 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Grape Seed Extract
Treatment: Drugs - Maltodextrin

Active comparator: Grape Seed Extract - Grape seed extract 600mg per day - 1 capsule per day

Placebo comparator: Maltodextrin - Maltodextrin - 1 capsule per day


Treatment: Drugs: Grape Seed Extract
One daily dose of 1 capsule containing 600mg grape seed extract

Treatment: Drugs: Maltodextrin
One daily dose of 1 capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Diastolic blood pressure (arm)
Timepoint [1] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [1] 0 0
Change in Systolic blood pressure (arm)
Timepoint [1] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [2] 0 0
Change in Peripheral systolic and diastolic blood pressure (leg)
Timepoint [2] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [3] 0 0
Change in HGB
Timepoint [3] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [4] 0 0
Change in WBC
Timepoint [4] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [5] 0 0
Change in RBC
Timepoint [5] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [6] 0 0
Change in Platelet Aggregation
Timepoint [6] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [7] 0 0
Change in (endothelial nitric oxide synthase) eNOS
Timepoint [7] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [8] 0 0
Change in endogenous nitric oxide (NO)
Timepoint [8] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [9] 0 0
Change in Tibial artery structure
Timepoint [9] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [10] 0 0
Change in blood flow of the right leg
Timepoint [10] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [11] 0 0
Change in oxygen saturation
Timepoint [11] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [12] 0 0
Change in resting pulse rate
Timepoint [12] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [13] 0 0
Change in weight
Timepoint [13] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [14] 0 0
Change in Body Mass Index (BMI)
Timepoint [14] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [15] 0 0
Change in waist and hip circumference
Timepoint [15] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [16] 0 0
Change in 36-Item Short Form Health Survey (SF-36)
Timepoint [16] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [17] 0 0
Change in E/LFT
Timepoint [17] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [18] 0 0
Change in triglycerides
Timepoint [18] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [19] 0 0
Change in cholesterol
Timepoint [19] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [20] 0 0
Change in blood glucose
Timepoint [20] 0 0
Baseline, week 4, week 8, week 11
Secondary outcome [21] 0 0
Change in adverse events
Timepoint [21] 0 0
Baseline, week 4, week 8, week 11

Eligibility
Key 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
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06440252
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06440252