Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the effects of a novel beverage rich in polyphenols (compounds present in fruit extracts) on risk factors associated with cardiovascular disease.

Detailed Description
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This study will assess the potential of a beverage containing plant and fruit extracts rich in polyphenolics to modulate vascular risk. Novel risk factors for vascular disease will be assessed including non-invasive assessment of vascular function by pulse wave analysis / pulse wave velocity and laser doppler iontophoresis.

Official Title
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Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Dietary Supplement: High polyphenol beverage
* Dietary Supplement: Placebo Beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 55 years BMI > 25 Exclusion Criteria: Present smoker or smoked within the last 2 years HBA1C > 6.0% eGFR<60 LFT >/= 3 times upper limit of normal Hypertension: systolic blood pressure > 160mmHg; diastolic blood pressure > 90mmHg, or on medication for hypertension. Chronic disease, likely to be clinically relevant (eg: cardiorespiratory, rheumatological, cerebrovascular or neoplastic disease) Vitamin supplements within the previous 14 days Medications which, in the opinion of the investigators, are known to influence vascular function (eg corticosteroids).

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Beverage<br> | Dietary Supplement: Placebo Beverage<br>* Antioxidant capacity umol TE/L(ORAC): negligible Polyphenolic Content(mcg/ml): negligible Vitamin C (mg/100ml): 0.00 Calorie Content (Kcal/250ml):40.0 250ml twice daily for 1 month (56 doses)<br>|
| Active Comparator: High Polyphenol Beverage<br> | Dietary Supplement: High polyphenol beverage<br>* Antioxidant capacity umol TE/L(ORAC): 19987 Polyphenolic Content(mcg/ml): 1445 Vitamin C (mg/100ml): 35.35 Calorie Content (Kcal/250ml):40.0 250ml twice daily for 1 month (56 doses)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity) |  | Baseline and post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Established and novel blood markers for vascular disease |  | baseline and post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyphenolics, flavonols, lipids, endothelial function, vascular risk factors