Circulatory; ChangePhase 3NCT06440252
Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults
A Phase 3 study testing Grape Seed Extract and Maltodextrin in people with Circulatory; Change, run by RDC Clinical Pty Ltd at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Circulatory; Change
- What is being tested?
- Grape Seed Extract and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Oct 2024to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
- Any participant that begins taking antiplatelet medication during the trial will be excluded from the study
- 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.
- An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study
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.
- Conditions
- Circulatory; Change
- Being tested
- Grape Seed Extract, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed ExtractDrug
One daily dose of 1 capsule containing 600mg grape seed extract
MaltodextrinDrug
One daily dose of 1 capsule
| Study group | Role | What they receive |
|---|---|---|
| Grape Seed Extract | Active comparator | Grape seed extract 600mg per day - 1 capsule per day Receives: Drug: Grape Seed Extract |
| Maltodextrin | Placebo comparator | Maltodextrin - 1 capsule per day Receives: Drug: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diastolic blood pressure (arm)
Change in Diastolic blood pressure (arm) as measured by blood pressure machine
Measured: Baseline, week 4, week 8, week 11
Secondary outcomes (21)
Change in Systolic blood pressure (arm)
Change in Systolic blood pressure (arm) as measured by blood pressure machine
Measured: Baseline, week 4, week 8, week 11
Change in Peripheral systolic and diastolic blood pressure (leg)
Change in Peripheral systolic and diastolic blood pressure (leg) as measured by blood pressure machine
Measured: Baseline, week 4, week 8, week 11
Change in HGB
Change in HGB as measured by FBC via blood test
Measured: Baseline, week 4, week 8, week 11
Change in WBC
Change in WBC as measured by FBC via blood test
Measured: Baseline, week 4, week 8, week 11
Change in RBC
Change in RBC as measured by FBC via blood test
Measured: Baseline, week 4, week 8, week 11
Change in Platelet Aggregation
Change in Platelet Aggregation as measured by FBC via blood test
Measured: Baseline, week 4, week 8, week 11
Change in (endothelial nitric oxide synthase) eNOS
Change in eNOS as measured via blood test
Measured: Baseline, week 4, week 8, week 11
Change in endogenous nitric oxide (NO)
Change in NO as measured via blood test
Measured: Baseline, week 4, week 8, week 11
Change in Tibial artery structure
Change in Tibial artery structure via Laser Doppler Flowmetry
Measured: 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
Measured: Baseline, week 4, week 8, week 11
Change in oxygen saturation
Change in oxygen saturation as measured by pulse oximeter
Measured: 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
Measured: Baseline, week 4, week 8, week 11
Change in weight
Change in weight as measure by digital scales
Measured: Baseline, week 4, week 8, week 11
Change in Body Mass Index (BMI)
Change in BMI as measured by weight and height calculation
Measured: Baseline, week 4, week 8, week 11
Change in waist and hip circumference
Change in waist and hip circumference as measured by tape measure
Measured: 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
Measured: Baseline, week 4, week 8, week 11
Change in E/LFT
Change in E/LFT as measured via blood test
Measured: Baseline, week 4, week 8, week 11
Change in triglycerides
Change in triglycerides as measured via blood test
Measured: Baseline, week 4, week 8, week 11
Change in cholesterol
Change in cholesterol as measured via blood test
Measured: Baseline, week 4, week 8, week 11
Change in blood glucose
Change in blood glucose as measured via blood test
Measured: Baseline, week 4, week 8, week 11
Change in adverse events
Change in adverse events as reported by participant
Measured: Baseline, week 4, week 8, week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start31 Oct 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory; ChangeStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440252
- Sponsor's protocol ID
- ALVCIR
- Status last verified
- Jul 2025
- First submitted
- 17 May 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults: a Randomised, Double-blind, Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT06440252
- Acronym / sponsor ID
- ALVCIR
- Conditions
- Circulatory; Change
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape Seed Extract | Active comparator | Drug: Grape Seed ExtractGrape seed extract 600mg per day - 1 capsule per day |
| Maltodextrin | Placebo comparator | Drug: MaltodextrinMaltodextrin - 1 capsule per day |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape Seed ExtractOne daily dose of 1 capsule containing 600mg grape seed extract | Drug | Grape Seed Extract |
| MaltodextrinOne daily dose of 1 capsule | Drug | Maltodextrin |
Primary outcome
Change in Diastolic blood pressure (arm)
Time frame: Baseline, week 4, week 8, week 11
Change in Diastolic blood pressure (arm) as measured by blood pressure machine
21 secondary outcomes
Change in Systolic blood pressure (arm)
Time frame: Baseline, week 4, week 8, week 11
Change in Peripheral systolic and diastolic blood pressure (leg)
Time frame: Baseline, week 4, week 8, week 11
Change in HGB
Time frame: Baseline, week 4, week 8, week 11
Change in WBC
Time frame: Baseline, week 4, week 8, week 11
Change in RBC
Time frame: Baseline, week 4, week 8, week 11
Change in Platelet Aggregation
Time frame: Baseline, week 4, week 8, week 11
Change in (endothelial nitric oxide synthase) eNOS
Time frame: Baseline, week 4, week 8, week 11
Change in endogenous nitric oxide (NO)
Time frame: Baseline, week 4, week 8, week 11
Change in Tibial artery structure
Time frame: Baseline, week 4, week 8, week 11
Change in blood flow of the right leg
Time frame: Baseline, week 4, week 8, week 11
Change in oxygen saturation
Time frame: Baseline, week 4, week 8, week 11
Change in resting pulse rate
Time frame: Baseline, week 4, week 8, week 11
Change in weight
Time frame: Baseline, week 4, week 8, week 11
Change in Body Mass Index (BMI)
Time frame: Baseline, week 4, week 8, week 11
Change in waist and hip circumference
Time frame: Baseline, week 4, week 8, week 11
Change in 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, week 4, week 8, week 11
Change in E/LFT
Time frame: Baseline, week 4, week 8, week 11
Change in triglycerides
Time frame: Baseline, week 4, week 8, week 11
Change in cholesterol
Time frame: Baseline, week 4, week 8, week 11
Change in blood glucose
Time frame: Baseline, week 4, week 8, week 11
Change in adverse events
Time frame: Baseline, week 4, week 8, week 11
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grape Seed Extract and Maltodextrin in people with Circulatory; Change, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diastolic blood pressure (arm) (time frame: Baseline, week 4, week 8, week 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.