Healthy Men and Women
Conditions
Keywords
vascular function, endothelial function, polyphenols, Concord Grape
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors
DIETARY_SUPPLEMENTConcord Grape extract 1
1 g Concord Grape extract in 2 capsules
DIETARY_SUPPLEMENTConcord Grape extract 2
500 mg Concord Grape extract in 2 capsules
Sponsors
Naturex-Dbs
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in flow mediated dilation (FMD) of the brachial artery | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in flow mediated dilation (FMD) of the brachial artery | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in systolic and diastolic blood pressure (mmHg) | 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 |
| Changes in heart rate (bpm) | 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 |
| Changes in blood lipids concentration (Total, HDL and LDL, cholesterol, triglycerides) | 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 |
| Percentage (%) of participants with any treatment-related adverse events | 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 |
Countries
United Kingdom
Outcome results
None listed