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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 because the information has not been verified recently.
Verified November 2008 by University of Glasgow.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00795834
First received: November 19, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795834

Contacts
Contact: Adam WF Mullan, MBChB MRCP +44-141-330-2569 a.mullan@clinmed.gla.ac.uk

Locations
United Kingdom
British Heart Foundation Glasgow Cardiovascular Research Centre Recruiting
Glasgow, United Kingdom, G12 8TA
Contact: Adam Mullan, MBChB BSc MRCP     +44-141-330-2569        
Sub-Investigator: Adam WF Mullan, BSc MBChB MRCP            
Sub-Investigator: William Ferrell, MBChB PhD FRCP            
Sub-Investigator: Christine Edwards, BSc PhD R.Nutr FHEA            
Sub-Investigator: Alan Crozier, BSc PhD            
Sub-Investigator: Gina Borges, MSc PhD            
Sponsors and Collaborators
University of Glasgow
Investigators
Principal Investigator: Naveed Sattar, MBChB PhD FRCPath FRCP University of Glasgow
  More Information

No publications provided

Responsible Party: Professor Naveed Sattar, University of Glasgow
ClinicalTrials.gov 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:
polyphenolics
flavonols
lipids
endothelial function
vascular risk factors

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013