Effect of Beta-Glucan on Cholesterol Lowering
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01408719|
Recruitment Status : Completed
First Posted : August 3, 2011
Results First Posted : March 11, 2014
Last Update Posted : November 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Dietary Supplement: Control Dietary Supplement: 3g LMW beta-glucan Dietary Supplement: 5g LMW beta-glucan Dietary Supplement: 3g HMW beta-glucan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of Beta-Glucan Molecular Weight and Viscosity on the Mechanism of Cholesterol Lowering in Humans|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: 5g LMW beta glucan
5 gram low molecular weight barley beta-glucan diet for 35 days
Dietary Supplement: Control
Experimental: 3g HMW beta glucan
3 gram high molecular weight barley beta-glucan diet for 35 days
Dietary Supplement: 3g LMW 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
- Changs in Total Cholesterol [ Time Frame: Beginning and end of each phase ]Fasted total cholesterol concentration will be measured using the automated enzymatic methods.
- Changes in LDL Cholesterol [ Time Frame: Beginning and end of each phase ]Serum LDL cholesterol will be estimated using the Friedewald equation.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408719
|Richardson Centre for Functional Foods and Neutraceuticals|
|Winnipeg, Manitoba, Canada, R3T 2N2|
|Principal Investigator:||Nancy Ames, PhD||AAFC|