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Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women (CONCARD)

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ClinicalTrials.gov Identifier: NCT03553225
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Naturex-Dbs
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Men and Women Dietary Supplement: Placebo Dietary Supplement: Concord Grape extract 1 Dietary Supplement: Concord Grape extract 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : May 17, 2019

Arm Intervention/treatment
Placebo Comparator: Placebo
Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsules regimen (1g)
Dietary Supplement: Placebo
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
Dietary Supplement: Concord Grape extract 1
1 g Concord Grape extract in 2 capsules

Active Comparator: Concord Grape Extract 2
500 mg Concord Grape Extract in 2 capsules
Dietary Supplement: Concord Grape extract 2
500 mg Concord Grape extract in 2 capsules




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553225


Locations
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United Kingdom
King's College London
London, Waterloo, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
Naturex-Dbs

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Responsible Party: Dr Ana Rodriguez-Mateos, Principle Investigator, King's College London
ClinicalTrials.gov Identifier: NCT03553225     History of Changes
Other Study ID Numbers: DBS12-CRG
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Ana Rodriguez-Mateos, King's College London:
vascular function
endothelial function
polyphenols
Concord Grape