Effect of Beta-Glucan on Cholesterol Lowering

NCT ID: NCT01408719

Last Updated: 2015-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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5g LMW beta glucan

5 gram low molecular weight barley beta-glucan diet for 35 days

Group Type EXPERIMENTAL

Control

Intervention Type DIETARY_SUPPLEMENT

Minimal beta-glucan

3g HMW beta glucan

3 gram high molecular weight barley beta-glucan diet for 35 days

Group Type EXPERIMENTAL

3g LMW beta-glucan

Intervention Type DIETARY_SUPPLEMENT

3grams beta-glucan

3g LMW beta glucan

3 grams of low molecular weight beta-glucan diet for 35 days

Group Type EXPERIMENTAL

5g LMW beta-glucan

Intervention Type DIETARY_SUPPLEMENT

5 grams beta-glucan

Control

control diet containing negligible amount of beta glucan

Group Type PLACEBO_COMPARATOR

3g HMW beta-glucan

Intervention Type DIETARY_SUPPLEMENT

3 grams of high molecular weight beta-glucan

Interventions

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Control

Minimal beta-glucan

Intervention Type DIETARY_SUPPLEMENT

3g LMW beta-glucan

3grams beta-glucan

Intervention Type DIETARY_SUPPLEMENT

5g LMW beta-glucan

5 grams beta-glucan

Intervention Type DIETARY_SUPPLEMENT

3g HMW beta-glucan

3 grams of high molecular weight beta-glucan

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nancy Ames

Research Scientist & Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Ames, PhD

Role: PRINCIPAL_INVESTIGATOR

AAFC

Locations

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Richardson Centre for Functional Foods and Neutraceuticals

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Wang Y, Harding SV, Eck P, Thandapilly SJ, Gamel TH, Abdel-Aal el-SM, Crow GH, Tosh SM, Jones PJ, Ames NP. High-Molecular-Weight beta-Glucan Decreases Serum Cholesterol Differentially Based on the CYP7A1 rs3808607 Polymorphism in Mildly Hypercholesterolemic Adults. J Nutr. 2016 Apr;146(4):720-7. doi: 10.3945/jn.115.223206. Epub 2016 Mar 2.

Reference Type DERIVED
PMID: 26936139 (View on PubMed)

Other Identifiers

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B2010:216

Identifier Type: -

Identifier Source: org_study_id

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