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

NCT ID: NCT03553225

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2019-05-17

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.

Conditions

Healthy Men and Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsules regimen (1g)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Identical formulation as the treatment consisting of colored maltodextrin using artificial colors

Concord Grape Extract 1

1 g Concord Grape Extract in 2 capsules

Group Type: ACTIVE_COMPARATOR

Concord Grape extract 1

Intervention Type: DIETARY_SUPPLEMENT

1 g Concord Grape extract in 2 capsules

Concord Grape Extract 2

500 mg Concord Grape Extract in 2 capsules

Group Type: ACTIVE_COMPARATOR

Concord Grape extract 2

Intervention Type: DIETARY_SUPPLEMENT

500 mg Concord Grape extract in 2 capsules

Interventions

Placebo

Identical formulation as the treatment consisting of colored maltodextrin using artificial colors

Intervention Type: DIETARY_SUPPLEMENT

Concord Grape extract 1

1 g Concord Grape extract in 2 capsules

Intervention Type: DIETARY_SUPPLEMENT

Concord Grape extract 2

500 mg Concord Grape extract in 2 capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Naturex-Dbs

INDUSTRY

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Dr Ana Rodriguez-Mateos

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King's College London

London, Waterloo, United Kingdom

Countries

United Kingdom

Other Identifiers

DBS12-CRG

Identifier Type: -

Identifier Source: org_study_id