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

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: Healthy Men and Women
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Concord Grape extract 1; Dietary supplement: Concord Grape extract 2

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Waterloo
    • London, Waterloo, United Kingdom, SE1 9NH
      • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in systolic and diastolic blood pressure (mmHg)	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)	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)	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	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

• Sponsor: King's College London
• Collaborators: Naturex-Dbs

Study record dates

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

• Keywords: vascular function; polyphenols; endothelial function; Concord Grape
• 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