This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments control, 3g lmw beta-glucan, 5g lmw beta-glucan, 3g hmw beta-glucan
Sponsor University of Manitoba
Collaborator Agriculture and Agri-Food Canada
Start date November 2010
End date March 2014
Trial size 45 participants
Trial identifier NCT01408719, B2010:216


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose prevention
Minimal barley and minimal beta-glucan
Minimal beta-glucan
3 gram high molecular weight barley beta-glucan diet for 35 days
3g lmw beta-glucan
3grams beta-glucan
3grams of low molecular weight beta-glucan diet for 35 days
5g lmw beta-glucan
5 grams beta-glucan
(Placebo Comparator)
control diet containing no beta glucan
3g hmw beta-glucan
3 grams of high molecular weight beta-glucan

Primary Outcomes

Total Cholesterol
time frame: 35 days

Eligibility Criteria

Male or female participants from 18 years up to 78 years old.

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

Additional Information

Official title Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans
Principal investigator Nancy Ames, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Manitoba.