Effects of a Beverage Rich in Fruit Extracts on Risk Factors Associated With Cardiovascular Disease
Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 19, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedNovember 21, 2008
November 1, 2008
7 months
November 19, 2008
November 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)
Baseline and post intervention
Secondary Outcomes (1)
Established and novel blood markers for vascular disease
baseline and post intervention
Study Arms (2)
Beverage
PLACEBO COMPARATORHigh Polyphenol Beverage
ACTIVE COMPARATORInterventions
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)
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)
Eligibility Criteria
You may qualify if:
- Age \>/= 55 years
- BMI \> 25
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
British Heart Foundation Glasgow Cardiovascular Research Centre
Glasgow, G12 8TA, United Kingdom
Related Publications (1)
Mullan A, Delles C, Ferrell W, Mullen W, Edwards CA, McColl JH, Roberts SA, Lean ME, Sattar N. Effects of a beverage rich in (poly)phenols on established and novel risk markers for vascular disease in medically uncomplicated overweight or obese subjects: A four week randomized placebo-controlled trial. Atherosclerosis. 2016 Mar;246:169-76. doi: 10.1016/j.atherosclerosis.2016.01.004. Epub 2016 Jan 6.
PMID: 26797134DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Naveed Sattar, MBChB PhD FRCPath FRCP
University of Glasgow
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 19, 2008
First Posted
November 21, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2009
Study Completion
March 1, 2009
Last Updated
November 21, 2008
Record last verified: 2008-11