Clinical trial NCT03553225: Randomized, Double-blind, Controlled Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men and Women
Keywords: vascular function
endothelial function
polyphenols
Concord Grape
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Naturex-Dbs
First posted: 2018-06-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Changes in flow mediated dilation (FMD) of the brachial artery
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in flow mediated dilation (FMD) of the brachial artery
timeFrame: 2 hours
Other outcomes:
measure: Changes in systolic and diastolic blood pressure (mmHg)
timeFrame: 12 weeks
measure: Changes in heart rate (bpm)
timeFrame: 12 weeks
measure: Changes in blood lipids concentration (Total, HDL and LDL, cholesterol, triglycerides)
timeFrame: 12 weeks
measure: Percentage (%) of participants with any treatment-related adverse events
timeFrame: 12 weeks
Locations:
city: London
country: United Kingdom
facility: King's College London
state: Waterloo
Study officials:
References: