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

Healthy Men and Women Clinical Trial

— CONCARD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553225
• Other study ID #: DBS12-CRG
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: July 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Men and Women

Intervention

Dietary Supplement:
• Placebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors
• Concord Grape extract 1
1 g Concord Grape extract in 2 capsules
• Concord Grape extract 2
500 mg Concord Grape extract in 2 capsules

Locations

Country	Name	City	State
United Kingdom	King's College London	London	Waterloo

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Naturex-Dbs

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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