NCT01408719

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 11, 2014

Completed
Last Updated

November 5, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

August 2, 2011

Results QC Date

August 12, 2013

Last Update Submit

October 7, 2015

Conditions

Hypercholesterolemia

Keywords

Beta-GlucanBarleyMolecular WeightViscosityCholesterolStable isotopeGene-nutrient interactionGut microbiota

Outcome Measures

Primary Outcomes (2)

  • Changs in Total Cholesterol

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

    Beginning and end of each phase

  • Changes in LDL Cholesterol

    Serum LDL cholesterol will be estimated using the Friedewald equation.

    Beginning and end of each phase

Secondary Outcomes (3)

  • Cholesterol Absorption/Synthesis

    End of each phase

  • Potential Gene-nutrient Interactions: CYP7A1 and APOE

    Once for each participant

  • Changes in Body Weight and Waist Circumference(WC)

    Every day for body weight; beginning and end of each phase for WC

Study Arms (4)

5g LMW beta glucan

EXPERIMENTAL

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

Dietary Supplement: Control

3g HMW beta glucan

EXPERIMENTAL

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

Dietary Supplement: 3g LMW beta-glucan

3g LMW beta glucan

EXPERIMENTAL

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

Dietary Supplement: 5g LMW beta-glucan

Control

PLACEBO COMPARATOR

control diet containing negligible amount of beta glucan

Dietary Supplement: 3g HMW beta-glucan

Interventions

ControlDIETARY_SUPPLEMENT

Minimal beta-glucan

5g LMW beta glucan
3g LMW beta-glucanDIETARY_SUPPLEMENT

3grams beta-glucan

3g HMW beta glucan
5g LMW beta-glucanDIETARY_SUPPLEMENT

5 grams beta-glucan

3g LMW beta glucan
3g HMW beta-glucanDIETARY_SUPPLEMENT

3 grams of high molecular weight beta-glucan

Control

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Neutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26936139DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Nancy Ames
Organization
Agriculture and Agri-food Canada
nancy.ames@agr.gc.ca
204-474-7187

Study Officials

  • Nancy Ames, PhD

    AAFC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist & Adjunct Professor

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 3, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 5, 2015

Results First Posted

March 11, 2014

Record last verified: 2015-10

Locations

CA(1)