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Completed

NCT Number: NCT01408719

Effect of Beta-Glucan on Cholesterol Lowering

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Functional Foods and Neutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Dietary Supplement

Minimal beta-glucan

3g LMW beta-glucan

Dietary Supplement

3grams beta-glucan

5g LMW beta-glucan

Dietary Supplement

5 grams beta-glucan

3g HMW beta-glucan

Dietary Supplement

3 grams of high molecular weight beta-glucan

Primary outcomes

  1. Changs in Total Cholesterol

    Time frame: Beginning and end of each phase

    Fasted total cholesterol concentration will be measured using the automated enzymatic methods.

  2. Changes in LDL Cholesterol

    Time frame: Beginning and end of each phase

    Serum LDL cholesterol will be estimated using the Friedewald equation.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Agriculture and Agri-Food Canada

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 3, 2011
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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