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

Not Applicable

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: High polyphenol beverage; Dietary Supplement: Placebo Beverage

• Registration Number: NCT00795834
• Lead Sponsor: University of Glasgow

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-06
• Status Verified: 2008-11
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Last Update Submitted: 2008-11-19
• Study First Posted: 2008-11-21
• Last Update Posted: 2008-11-21
• Primary Completion: 2009-01
• Study Completion: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Polyphenol Beverage	High polyphenol beverage	-
Beverage	Placebo Beverage	-

Primary Outcome Measures

Name	Time	Method
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)	Baseline and post intervention

Secondary Outcome Measures

Name	Time	Method
Established and novel blood markers for vascular disease	baseline and post intervention

Trial Locations

Locations (1)

British Heart Foundation Glasgow Cardiovascular Research Centre; 🇬🇧 Glasgow, United Kingdom