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| Name | Class |
|---|---|
| Agriculture and Agri-Food Canada | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5g LMW beta glucan | Experimental | 5 gram low molecular weight barley beta-glucan diet for 35 days |
|
| 3g HMW beta glucan | Experimental | 3 gram high molecular weight barley beta-glucan diet for 35 days |
|
| 3g LMW beta glucan | Experimental | 3 grams of low molecular weight beta-glucan diet for 35 days |
|
| Control | Placebo Comparator | control diet containing negligible amount of beta glucan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Dietary Supplement | Minimal beta-glucan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol Absorption/Synthesis | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Ames, PhD | AAFC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richardson Centre for Functional Foods and Neutraceuticals | Winnipeg | Manitoba | R3T 2N2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26936139 | Derived | 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. |
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Over 200 subjects were screened; 45 subjects were enrolled in the study and randomly assigned to the experimental diets (treatment groups).
Participants were recruited at the Richardson Centre for Functionals Foods and Nutraceuticals, University of Manitoba, Winnipeg during July 2010 to May 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | 3g LMW followed by control, followed by 3g HMW, followed by 5g LMW |
| FG001 | Sequence 2 | Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW |
| FG002 | Sequence 3 | 3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control |
| FG003 | Sequence 4 | 5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control |
| FG004 | Sequence 5 | 3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW |
| FG005 | Sequence 6 | control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW |
| FG006 | Sequence 7 | 5g LMW, followed by 3g LMW, followed control, followed by 3g HMW |
| FG007 | Sequence 8 | 3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW |
| FG008 | Sequence 9 | Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW |
| FG009 | Sequence 10 | Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW |
| FG010 | Sequence 11 | 3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW |
| FG011 | Sequence 12 | 5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW |
| FG012 | Sequence 13 | 3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW |
| FG013 | Sequence 14 | 3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control |
| FG014 | Sequence 15 | 3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW |
| FG015 | Sequence 16 | 3g HMW, followed by 5g LMW, followed 3g LMW, followed by control |
| FG016 | Sequence 17 | 3g HMW, followed by 3g LMW, followed 5g LMW, followed by control |
| FG017 | Sequence 18 | 5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW |
| FG018 | Sequence 19 | Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW |
| FG019 | Sequence 20 | 3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (35 Days) |
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| Washout Period (28 Days) |
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| Second Intervention (35 Days) |
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| Washout Period (28 Days) |
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| Third Intervention (35 Days) |
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| Washout Period (28 Days) |
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| Fourth Intervention (35 Days) |
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It is a cross over trial so the total number of participants is same throughout the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | 3g LMW followed by control, followed by 3g HMW, followed by 5g LMW |
| BG001 | Sequence 2 | Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changs in Total Cholesterol | Fasted total cholesterol concentration will be measured using the automated enzymatic methods. | Posted | Least Squares Mean | Standard Error | mmol/L | Beginning and end of each phase |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Minimal barley and minimal beta-glucan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nancy Ames | Agriculture and Agri-food Canada | 204-474-7187 | nancy.ames@agr.gc.ca |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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 |
|
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) | 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 |
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| COMPLETED |
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| BG002 | Sequence 3 | 3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control |
| BG003 | Sequence 4 | 5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control |
| BG004 | Sequence 5 | 3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW |
| BG005 | Sequence 6 | control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW |
| BG006 | Sequence 7 | 5g LMW, followed by 3g LMW, followed control, followed by 3g HMW |
| BG007 | Sequence 8 | 3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW |
| BG008 | Sequence 9 | Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW |
| BG009 | Sequence 10 | Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW |
| BG010 | Sequence 11 | 3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW |
| BG011 | Sequence 12 | 5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW |
| BG012 | Sequence 13 | 3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW |
| BG013 | Sequence 14 | 3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control |
| BG014 | Sequence 15 | 3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW |
| BG015 | Sequence 16 | 3g HMW, followed by 5g LMW, followed 3g LMW, followed by control |
| BG016 | Sequence 17 | 3g HMW, followed by 3g LMW, followed 5g LMW, followed by control |
| BG017 | Sequence 18 | 5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW |
| BG018 | Sequence 19 | Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW |
| BG019 | Sequence 20 | 3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW |
| BG020 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
3 grams of low molecular weight beta-glucan diet for 35 days 5g LMW beta-glucan: 5 grams beta-glucan |
| OG003 | Control | control diet containing negligible amount of beta glucan 3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan |
|
|
| Secondary | Cholesterol Absorption/Synthesis | The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique. | Not Posted | End of each phase |
| Secondary | Potential Gene-nutrient Interactions: CYP7A1 and APOE | 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. | Not Posted | Once for each participant |
| Primary | Changes in LDL Cholesterol | Serum LDL cholesterol will be estimated using the Friedewald equation. | Not Posted | Beginning and end of each phase |
| Secondary | Changes in Body Weight and Waist Circumference(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. | Not Posted | Every day for body weight; beginning and end of each phase for WC |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 3g HMW Beta-glucan | 3 grams high molecular weight barley beta-glucan | 0 | 35 | 0 | 35 |
| EG002 | 3g LMW Beta-glucan | 3 grams low molecular weight barley beta-glucan | 0 | 35 | 0 | 35 |
| EG003 | 5g LMW Beta-glucan | 5 grams low molecular weight barley beta-glucan | 0 | 35 | 0 | 35 |
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| D009750 |
| Nutritional and Metabolic Diseases |