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

November 19, 2008 updated by: University of Glasgow

Pilot Study to Assess Effects of Novel Beverages on Established and Novel Risk Markers for Vascular Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 8TA
        • Recruiting
        • British Heart Foundation Glasgow Cardiovascular Research Centre
        • Contact:
          • Adam Mullan, MBChB BSc MRCP
          • Phone Number: +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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular Function (measured by Laser Doppler Iontophoresis and Pulse Wave Analysis / Pulse Wave Velocity)
Time Frame: Baseline and post intervention
Baseline and post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Established and novel blood markers for vascular disease
Time Frame: baseline and post intervention
baseline and post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Investigators

  • Principal Investigator: Naveed Sattar, MBChB PhD FRCPath FRCP, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ANTICIPATED)

January 1, 2009

Study Completion (ANTICIPATED)

March 1, 2009

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (ESTIMATE)

November 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2008

Last Update Submitted That Met QC Criteria

November 19, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/S0704/110
  • RN08BI013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe