Healthy Men and WomenCONCARDNCT03553225
Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women
A study testing Concord Grape extract 1 and Concord Grape extract 2 in people with Healthy Men and Women, run by King's College London at 1 site in United Kingdom.
Trial summary
Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols, procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG) consumption on cardiovascular disease (CVD) risk have provided mixed results. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- Concord Grape extract 1 and Concord Grape extract 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2018to 17 May 2019
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women (pre and post-menopausal) aged 18-40 years
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- Are able to understand the nature of the study
- Able to give signed written informed consent
- Signed informed consent form
Who cannot join
- Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Hypertensive, as defined as SBP superior or equal to 140 mmHg
- Obese participants, defined as BMI superior or equal to 30 kg/m2
- Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
- Abnormal heart rhythm (lower or higher than 60-100 bmp)
- Allergies to berries or other significant food allergy
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- Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
- Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
- Subjects who reported participant in another study within one month before the study start
- Subjects who smoke an irregular amount of cigarettes per day
- Pregnant women or planning to become pregnant in the next 6 months
- Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo Controlled, Parallel Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women
Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols, procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG) consumption on cardiovascular disease (CVD) risk have provided mixed results. Studies were limited by small sample size or lacked a control arm. Moreover, subjects presented with CVD or CVD risk factors and thus to our knowledge, it remains unknown as to whether the consumption of Concord Grape (poly)phenols can maintain vascular function in healthy individuals. The aim of this study is therefore to examine both acute and chronic effects of Concord Grape on cardiovascular health by investigating whether daily consumption of Concord Grape Extract (CGE) for 12 weeks can affect biomarkers of CVD risk, including endothelial function, blood pressure and blood lipids, in young healthy men and women.
- Conditions
- Healthy Men and Women
- Being tested
- Placebo, Concord Grape extract 1, Concord Grape extract 2
- Keywords
- vascular function, endothelial function, polyphenols, Concord Grape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors
Concord Grape extract 1Dietary supplement
1 g Concord Grape extract in 2 capsules
Concord Grape extract 2Dietary supplement
500 mg Concord Grape extract in 2 capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsules regimen (1g) Receives: Dietary Supplement: Placebo |
| Concord Grape Extract 1 | Active comparator | 1 g Concord Grape Extract in 2 capsules Receives: Dietary Supplement: Concord Grape extract 1 |
| Concord Grape Extract 2 | Active comparator | 500 mg Concord Grape Extract in 2 capsules Receives: Dietary Supplement: Concord Grape extract 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in flow mediated dilation (FMD) of the brachial artery
Determine changes in flow mediated dilation (FMD) of the brachial artery after 12 week consumption of 500 mg or 1 g of Concord grape extract vs. Placebo
Measured: 12 weeks
Secondary outcomes (1)
Changes in flow mediated dilation (FMD) of the brachial artery
Determine changes in flow mediated dilation (FMD) of the brachial artery between 2 hours post consumption of 500 mg or 1 g of Concord grape extract vs. Placebo on day 0 and 2 h post consumption of 500 mg and 1 g Concard Grape extract vs. Placebo on day 84
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start17 Jul 2018
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and WomenStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex-Dbs
- Responsible party
- Principal investigator, Dr Ana Rodriguez-Mateos, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553225
- Sponsor's protocol ID
- DBS12-CRG
- Acronym
- CONCARD
- Status last verified
- Jul 2019
- First submitted
- 29 May 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo Controlled, Parallel Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT03553225
- Acronym / sponsor ID
- CONCARD / DBS12-CRG
- Conditions
- Healthy Men and Women
- Keywords
- vascular function, endothelial function, polyphenols, Concord Grape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Naturex-Dbs
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 12 Jun 2018 (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.
Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols, procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG) consumption on cardiovascular disease (CVD) risk have provided mixed results. Studies were limited by small sample size or lacked a control arm. Moreover, subjects presented with CVD or CVD risk factors and thus to our knowledge, it remains unknown as to whether the consumption of Concord Grape (poly)phenols can maintain vascular function in healthy individuals. The aim of this study is therefore to examine both acute and chronic effects of Concord Grape on cardiovascular health by investigating whether daily consumption of Concord Grape Extract (CGE) for 12 weeks can affect biomarkers of CVD risk, including endothelial function, blood pressure and blood lipids, in young healthy men and women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFormulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsules regimen (1g) |
| Concord Grape Extract 1 | Active comparator | Dietary Supplement: Concord Grape extract 11 g Concord Grape Extract in 2 capsules |
| Concord Grape Extract 2 | Active comparator | Dietary Supplement: Concord Grape extract 2500 mg Concord Grape Extract in 2 capsules |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men and women (pre and post-menopausal) aged 18-40 years
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- Are able to understand the nature of the study
- Able to give signed written informed consent
- Signed informed consent form
Key exclusion criteria (12 listed)
- Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Hypertensive, as defined as SBP superior or equal to 140 mmHg
- Obese participants, defined as BMI superior or equal to 30 kg/m2
- Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
- Abnormal heart rhythm (lower or higher than 60-100 bmp)
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 |
|---|---|---|
| PlaceboIdentical formulation as the treatment consisting of colored maltodextrin using artificial colors | Dietary supplement | Placebo |
| Concord Grape extract 11 g Concord Grape extract in 2 capsules | Dietary supplement | Concord Grape Extract 1 |
| Concord Grape extract 2500 mg Concord Grape extract in 2 capsules | Dietary supplement | Concord Grape Extract 2 |
Primary outcome
Changes in flow mediated dilation (FMD) of the brachial artery
Time frame: 12 weeks
Determine changes in flow mediated dilation (FMD) of the brachial artery after 12 week consumption of 500 mg or 1 g of Concord grape extract vs. Placebo
1 secondary outcome
Changes in flow mediated dilation (FMD) of the brachial artery
Time frame: 2 hours
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 9 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concord Grape extract 1 and Concord Grape extract 2 in people with Healthy Men and Women, run by King's College London at 1 site in United Kingdom.
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 5 inclusion and 12 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 9 Jul 2019. 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 United Kingdom. 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.
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?
Changes in flow mediated dilation (FMD) of the brachial artery (time frame: 12 weeks). 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 9 Jul 2019.