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 (Responsible Party):
Dr. Nancy Ames, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01408719
First received: August 2, 2011
Last updated: January 24, 2014
Last verified: January 2014
  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
Hypercholesterolemia
Dietary Supplement: Control
Dietary Supplement: 3g LMW beta-glucan
Dietary Supplement: 5g LMW beta-glucan
Dietary Supplement: 3g HMW 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:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Total Cholesterol [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5g LMW beta glucan
Minimal barley and minimal beta-glucan
Dietary Supplement: Control
Minimal beta-glucan
Experimental: 3g HMW beta glucan
3 gram high molecular weight barley beta-glucan diet for 35 days
Dietary Supplement: 3g LMW beta-glucan
3grams beta-glucan
Experimental: 3g LMW beta glucan
3grams of low molecular weight beta-glucan diet for 35 days
Dietary Supplement: 5g LMW beta-glucan
5 grams beta-glucan
Placebo Comparator: Control
control diet containing no beta glucan
Dietary Supplement: 3g HMW beta-glucan
3 grams of high molecular weight 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 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 20-40 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
Investigators
Principal Investigator: Nancy Ames, PhD AAFC
  More Information

No publications provided

Responsible Party: Dr. Nancy Ames, Research Scientist & Adjunct Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01408719     History of Changes
Other Study ID Numbers: B2010:216
Study First Received: August 2, 2011
Results First Received: August 12, 2013
Last Updated: January 24, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 21, 2014