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Effect of Beta-Glucan on Cholesterol Lowering

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01408719
First received: August 2, 2011
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this project is to study how the soluble fibre component of barley foods lower blood cholesterol levels when these foods are incorporated into a healthy diet.


Condition Intervention
Above Optimal Blood Cholesterol
 Dietary Supplement: Control
Dietary Supplement: Low molecular weight/low viscosity beta-glucan
Dietary Supplement: High molecular weight/high viscosity beta glucan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Blood cholesterol [ Time Frame: 35 days ] [ Designated as safety issue: No ]
    Total and LDL cholesterol lowering


Secondary Outcome Measures:
  • Cholesterol absorption [ Time Frame: 35 days ] [ Designated as safety issue: No ]
    Stable isotope experiment to measure cholesterol absorption at the end of each study phase.

  • Cholesterol synthesis [ Time Frame: 35 days ] [ Designated as safety issue: No ]
    Stable isotope experiment to measure cholesterol synthesis at the end of each study phase


Estimated Enrollment: 37
Study Start Date: November 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Minimal barley and minimal beta-glucan
 Dietary Supplement: Control
Minimal beta-glucan
Experimental: Low molecular weight/low viscosity beta-glucan- 3 grams
3 grams of beta-glucan
 Dietary Supplement: Low molecular weight/low viscosity beta-glucan
3g beta-glucan
Experimental: Low molecular weight/low viscosity beta-glucan-5 grams
5 grams of beta-glucan
 Dietary Supplement: Low molecular weight/low viscosity beta-glucan
5 grams beta-glucan
Experimental: High molecular weight/ high viscosity beta-glucan
3 grams of beta-glucan
 Dietary Supplement: High molecular weight/high viscosity beta glucan
3 grams of beta-glucan

Detailed Description:

This study consists of four dietary phases which are separated by at least 21 days wash-out period. While participating in a treatment phase, the Richardson Centre will provide subjects with all meals for the 35 day period. Breakfast meals will be consumed under the supervision of the research staff and lunch, dinner and snacks will be provided to take home in take-out packaging. While subjects are on the wash-out period they will return to their normal diet. The meals are on a 7 day rotating schedule that reflect an average Canadian diet.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 20-35 kg/m2
  • Fasting cholesterol levels of 5.0-8.0 mmol/L
  • Fasting serum LDL cholesterol levels of 2.7-5.0 mmol/L

Exclusion Criteria:

  • Pregnant or lactating
  • Taking lipid lowering medication or nutritional supplements that affect blood lipids
  • Not deemed healthy by study physician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408719

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Neutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Agriculture and Agri-Food Canada
  More Information

No publications provided

Responsible Party: Dr. Nancy Ames, Agriculture and Agri-Food Canada
ClinicalTrials.gov Identifier: NCT01408719     History of Changes
Other Study ID Numbers: B2010:216
Study First Received: August 2, 2011
Last Updated: August 8, 2011
Health Authority: Canada: Health Canada and Agriculture and Agri-Food Canada

Keywords provided by University of Manitoba:
Beta-Glucan
Barley
Molecular Weight
 Viscosity
Cholesterol
Stable isotopes

ClinicalTrials.gov processed this record on May 19, 2013