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

• Sponsor: King's College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03553225
• Collaborator: Naturex-Dbs (Industry)
• Enrollment: 66
• Location: 1
• Arms: 3
• Actual Duration (Months): 10
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jul 17, 2018
• Actual Primary Completion Date: May 17, 2019
• Actual Study Completion Date: May 17, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in flow mediated dilation (FMD) of the brachial artery [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 [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) [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) [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) [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King's College London	London	Waterloo	United Kingdom	SE1 9NH

Sponsors and Collaborators

• King's College London
• Naturex-Dbs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Ana Rodriguez-Mateos, Principle Investigator, King's College London
• ClinicalTrials.gov Identifier: NCT03553225
• Other Study ID Numbers: DBS12-CRG
• First Posted: Jun 12, 2018
• Last Update Posted: Jul 9, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Principle Investigator, King's College London: vascular function; endothelial function; polyphenols; Concord Grape

Study Results

No Results Posted as of Jul 9, 2019