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

NCT03553225 | Completed

• 1 other identifier: DBS12-CRG
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

vascular function; endothelial function; polyphenols; Concord Grape

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in flow mediated dilation (FMD) of the brachial artery

  2 hours

Other Outcomes (4)

• Changes in systolic and diastolic blood pressure (mmHg)

  12 weeks

• Changes in heart rate (bpm)

  12 weeks

• Changes in blood lipids concentration (Total, HDL and LDL, cholesterol, triglycerides)

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Concord Grape Extract 1

ACTIVE COMPARATOR

1 g Concord Grape Extract in 2 capsules

Dietary Supplement: Concord Grape extract 1

Concord Grape Extract 2

ACTIVE COMPARATOR

500 mg Concord Grape Extract in 2 capsules

Dietary Supplement: Concord Grape extract 2

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

Concord Grape extract 1 DIETARY_SUPPLEMENT

1 g Concord Grape extract in 2 capsules

Concord Grape Extract 1

Concord Grape extract 2 DIETARY_SUPPLEMENT

500 mg Concord Grape extract in 2 capsules

Concord Grape Extract 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Naturex-Dbs: collaborator

Study Sites (1)

King's College London

London, Waterloo, SE1 9NH, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: July 17, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)