Effect of Beta-Glucan on Cholesterol Lowering

October 7, 2015 updated by: Dr. Nancy Ames, University of Manitoba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

45

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • Richardson Centre for Functional Foods and Neutraceuticals

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

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5g LMW beta glucan
5 gram low molecular weight barley beta-glucan diet for 35 days
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
3 grams 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 negligible amount of beta glucan
Dietary supplement: 3g HMW beta-glucan
3 grams of high molecular weight beta-glucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changs in Total Cholesterol
Time Frame: Beginning and end of each phase
Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
Beginning and end of each phase
Changes in LDL Cholesterol
Time Frame: Beginning and end of each phase
Serum LDL cholesterol will be estimated using the Friedewald equation.
Beginning and end of each phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol Absorption/Synthesis
Time Frame: End of each phase
The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.
End of each phase
Potential Gene-nutrient Interactions: CYP7A1 and APOE
Time Frame: Once for each participant
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
Changes in Body Weight and Waist Circumference(WC)
Time Frame: Every day for body weight; beginning and end of each phase for 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

Collaborators and Investigators

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

Sponsor

University of Manitoba

Collaborators

Agriculture and Agri-Food Canada

Investigators

  • Principal Investigator: Nancy Ames, PhD, AAFC

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

November 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2010:216

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.

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