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| Name | Class |
|---|---|
| CreaNutrition, AG | UNKNOWN |
| University of Guelph | OTHER |
| University of Sydney | OTHER |
| Laval University |
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The purposes of this study were:
The FDA allows a health claim that oat products may reduce the risk of heart disease, based on meta-analyses showing a cholesterol-lowering effect of oat beta-glucan, if the product delivers at least a 3g daily dose of oat beta-glucan. However, not all studies have demonstrated a lowering of oat products. This may be due to variable bioactivity of the beta-glucan in the oat products. The bioactivity of oat beta-glucan is believed to depend upon its viscosity in the gut. Factors influencing viscosity include the molecular weight (MW) of the beta-glucan molecule and the amount of soluble beta-glucan in the product, which, in turn determines its concentration (C) in solution. In finished food products both MW and C can be modified by beta-glucanase enzymes present in other ingredients in the food (eg. wheat flour), processing (eg. extrusion) and storage (eg. freezing of moist products such as muffins). The effect of altering the MW and solubility of beta-glucan in foods on glycemic responses has been shown, but a role for MW and C in cholesterol lowering has not been established.
To address this issue, this study was designed with 2 primary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Wheat bran cereal |
|
| 3g high MW | Active Comparator | Cereal containing 3g high molecular weight oat beta glucan |
|
| 4g medium MW | Active Comparator | Cereal containing 4g oat beta glucan with medium molecular weight |
|
| 3g medium MW | Active Comparator | Cereal containing 3g oat beta glucan with medium molecular weight |
|
| 4g low MW | Active Comparator | Cereal containing 4g oat beta glucan with low molecular weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat bran | Dietary Supplement | 21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan | 4 weeks | |
| Correlation between serum LDL-cholesterol lowering and log(MW*C) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | 4 weeks | |
| Serum triglycerides | 4 weeks | |
| Serum HDL cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas MS Wolever, MD, PhD | Glycemic Index Laboratories, Inc | Principal Investigator |
| Peter J Wood, PhD | Agriculture and Agri-Food Canada | Study Director |
| Susan M Tosh, PhD | Agriculture and Agri-Food Canada | Study Director |
| Alison L Gibbs, PhD | Department of Statistics, University of Toronto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney | Sydney | New South Wales | 2006 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20660224 | Result | Wolever TM, Tosh SM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Thomson BA, Duss R, Wood PJ. Physicochemical properties of oat beta-glucan influence its ability to reduce serum LDL cholesterol in humans: a randomized clinical trial. Am J Clin Nutr. 2010 Oct;92(4):723-32. doi: 10.3945/ajcn.2010.29174. Epub 2010 Jul 21. | |
| 20527967 |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| OTHER |
| Reading Scientific Services Ltd. | INDUSTRY |
| University of Toronto | OTHER |
| Agriculture and Agri-Food Canada | OTHER_GOV |
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| 3g high MW | Dietary Supplement | 20.2 grams per day of ready to eat cereal containing 6g total dietary fiber and 3g oat beta glucan with high molecular weight |
|
| 4g medium MW | Dietary Supplement | 28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight |
|
| 3g medium MW | Dietary Supplement | 21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight |
|
| 4g low MW | Dietary Supplement | 28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight |
|
| 4 weeks |
| Fasting serum glucose | 4 weeks |
| Serum aspartate transaminase | 4 weeks |
| serum c-reactive protein | 4 weeks |
| Serum urea | 4 weeks |
| Serum creatinine | 4 weeks |
| Time course of changes in blood lipids | 4 weeks |
| Blood pressure | 4 weeks |
| Macronutrient composition of diet | 4 weeks |
| Symptoms questionnaire | 4 weeks |
| apolipoprotein B | 4 weeks |
| Serum markers of cholesterol absorption and synthesis | 4 weeks |
| Human Nutraceutical Research Unit, Department of Human Health and Nutritional Sciences, University of Guelph | Guelph | Ontario | N1G 2W1 | Canada |
| Glycemic Index Laboratories, Inc. | Toronto | Ontario | M5C 2X3 | Canada |
| Nutraceuticals and Functional Foods Institute, Faculte des science de l'agriculture et de l'alimentation, Universite Laval | Laval | Quebec | Canada |
| Reading Scientific Services, Ltd (RSSL) | Reading | Berkshire | RG6 6LA | United Kingdom |
| Tosh SM, Brummer Y, Miller SS, Regand A, Defelice C, Duss R, Wolever TM, Wood PJ. Processing affects the physicochemical properties of beta-glucan in oat bran cereal. J Agric Food Chem. 2010 Jul 14;58(13):7723-30. doi: 10.1021/jf904553u. |
| 22118569 | Derived | Wolever TM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Tosh SM, Duss R. Bioactive oat beta-glucan reduces LDL cholesterol in Caucasians and non-Caucasians. Nutr J. 2011 Nov 25;10:130. doi: 10.1186/1475-2891-10-130. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |