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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by University of Glasgow.
Recruitment status was:  Recruiting
Information provided by:
University of Glasgow Identifier:
First received: November 19, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
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.

Condition Intervention
Cardiovascular Disease
Dietary Supplement: High polyphenol beverage
Dietary Supplement: Placebo Beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease

Resource links provided by NLM:

Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity) [ Time Frame: Baseline and post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Established and novel blood markers for vascular disease [ Time Frame: baseline and post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Beverage Dietary Supplement: Placebo Beverage

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)

Active Comparator: High Polyphenol Beverage Dietary Supplement: High polyphenol beverage

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)

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.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00795834

United Kingdom
British Heart Foundation Glasgow Cardiovascular Research Centre
Glasgow, United Kingdom, G12 8TA
Sponsors and Collaborators
University of Glasgow
Principal Investigator: Naveed Sattar, MBChB PhD FRCPath FRCP University of Glasgow
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor Naveed Sattar, University of Glasgow Identifier: NCT00795834     History of Changes
Other Study ID Numbers: 07/S0704/110  RN08BI013 
Study First Received: November 19, 2008
Last Updated: November 19, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Glasgow:
endothelial function
vascular risk factors

Additional relevant MeSH terms:
Cardiovascular Diseases processed this record on December 09, 2016