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Completed

NCT Number: NCT03553225

Randomized, Double-blind, Controlled 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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, Waterloo, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

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

Concord Grape extract 1

Dietary Supplement

1 g Concord Grape extract in 2 capsules

Concord Grape extract 2

Dietary Supplement

500 mg Concord Grape extract in 2 capsules

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Naturex-Dbs

Registry information

Official study title

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

Acronym: CONCARD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2018
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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