- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553225
Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women (CONCARD)
July 8, 2019 updated by: Dr Ana Rodriguez-Mateos, King's College London
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Waterloo
-
London, Waterloo, United Kingdom, SE1 9NH
- King's College London
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsules regimen (1g)
|
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors
|
Active Comparator: Concord Grape Extract 1
1 g Concord Grape Extract in 2 capsules
|
1 g Concord Grape extract in 2 capsules
|
Active Comparator: Concord Grape Extract 2
500 mg Concord Grape Extract in 2 capsules
|
500 mg Concord Grape extract in 2 capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in flow mediated dilation (FMD) of the brachial artery
Time Frame: 2 hours
|
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
|
2 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in systolic and diastolic blood pressure (mmHg)
Time Frame: 12 weeks
|
Determine changes in systolic and diastolic blood pressure (mmHg) at baseline and 2 hours post consumption of 500 mg and 1 g of Concord Grape extract on day 1 and day 84
|
12 weeks
|
Changes in heart rate (bpm)
Time Frame: 12 weeks
|
Determine changes in heart rate (bpm) at baseline and 2 hours post consumption of 500 mg and 1 g of Concord Grape extract on day 1 and day 84
|
12 weeks
|
Changes in blood lipids concentration (Total, HDL and LDL, cholesterol, triglycerides)
Time Frame: 12 weeks
|
Determine changes in blood lipids concentration (Total, HDL and LDL, cholesterol, triglycerides) after 84 days post consumption of 500 mg or 1 g Concord Grape extract vs. Placebo
|
12 weeks
|
Percentage (%) of participants with any treatment-related adverse events
Time Frame: 12 weeks
|
Determine safety and tolerability of 500 mg and 1 g of Concord Grape extract vs. Placebo (%) as per any treatment-related adverse events
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2018
Primary Completion (Actual)
May 17, 2019
Study Completion (Actual)
May 17, 2019
Study Registration Dates
First Submitted
May 29, 2018
First Submitted That Met QC Criteria
June 11, 2018
First Posted (Actual)
June 12, 2018
Study Record Updates
Last Update Posted (Actual)
July 9, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- DBS12-CRG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Men and Women
-
USDA Beltsville Human Nutrition Research CenterCompleted
-
King's College LondonCompletedHealthy Men and WomenUnited Kingdom
-
King's College LondonLucozade Ribena SuntoryCompletedHealthy Men and WomenUnited Kingdom
-
Société des Produits Nestlé (SPN)Active, not recruitingHealthy Men and WomenSwitzerland
-
King's College LondonCompleted
-
King's College LondonLucozade Ribena SuntoryCompletedHealthy Men and WomenUnited Kingdom
-
Metabolic Technologies Inc.CompletedHealthy Men and WomenUnited States
-
King's College LondonCompletedHealthy Men and WomenUnited Kingdom
-
AmgenCompleted
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States