Effect of Beta-Glucan on Cholesterol Lowering

Hypercholesterolemia Clinical Trial

Official title:

Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408719
• Other study ID #: B2010:216
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: October 7, 2015
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed. Our second aim is to investigate the mechanism responsible for the action, specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet interactions are associated with cholesterol lowering by barley β-glucan. In addition, we aim to investigate the alteration of the gut microbiota after β-glucan consumption and the correlation between the altered gut microbiota and cardiovascular disease risk factors.

Description:

This study consists of four dietary phases which are separated by >28 days wash-out period. During the treatment phase, participants will be provided 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. Changes in blood lipids, body weight, and waist circumference will be measured during each treatment phase. Cholesterol absorption and synthesis will be examined by stable isotope method. Single nucleotide polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined byTaqMan® SNP Genotyping assay following the manufacturer's protocol. Fecal samples will be collected at the end of each intervention phase and will be subjected to Illumina sequencing of 16S rRNA genes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

• Dietary restrictions which would affect consuming the study diet for 5-wk for four study phases.

• Not deemed healthy by study physician

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Control
Minimal beta-glucan
• 3g LMW beta-glucan
3grams beta-glucan
• 5g LMW beta-glucan
5 grams beta-glucan
• 3g HMW beta-glucan
3 grams of high molecular weight beta-glucan

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Neutraceuticals	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Agriculture and Agri-Food Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changs in Total Cholesterol	Fasted total cholesterol concentration will be measured using the automated enzymatic methods.	Beginning and end of each phase	No
Primary	Changes in LDL Cholesterol	Serum LDL cholesterol will be estimated using the Friedewald equation.	Beginning and end of each phase	No
Secondary	Cholesterol Absorption/Synthesis	The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.	End of each phase	No
Secondary	Potential Gene-nutrient Interactions: CYP7A1 and APOE	The Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.	Once for each participant	No
Secondary	Changes in Body Weight and Waist Circumference(WC)	Body weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.	Every day for body weight; beginning and end of each phase for WC	No