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

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ClinicalTrials.gov Identifier: NCT00795834
Recruitment Status : Unknown
Verified November 2008 by University of Glasgow.
Recruitment status was:  Recruiting
First Posted : November 21, 2008
Last Update Posted : November 21, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: High polyphenol beverage Dietary Supplement: Placebo Beverage Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease
Study Start Date : June 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)





Primary Outcome Measures :
  1. Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity) [ Time Frame: Baseline and post intervention ]

Secondary Outcome Measures :
  1. Established and novel blood markers for vascular disease [ Time Frame: baseline and post intervention ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Naveed Sattar, University of Glasgow
ClinicalTrials.gov Identifier: NCT00795834     History of Changes
Other Study ID Numbers: 07/S0704/110
RN08BI013
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Cardiovascular Diseases