Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol
NCT ID: NCT00981981
Last Updated: 2011-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
367 participants
INTERVENTIONAL
2008-11-30
2009-08-31
Brief Summary
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1. To determine if a breakfast cereal containing 3g of high molecular weight oat beta-glucan fiber would lower low-density lipoprotein (LDL) - cholesterol (the "bad" cholesterol) compared to a control cereal containing wheat fiber.
2. To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced when the molecular weight of the fiber was reduced.
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Detailed Description
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To address this issue, this study was designed with 2 primary objectives:
1. An extruded oat cereal containing 3g high-molecular weight oat β-glucan daily will reduce LDL cholesterol compared to a control wheat bran cereal.
2. A significant correlation exists between LDL cholesterol and log(C×MW), where C is the amount of soluble β-glucan in the daily dose of cereal and MW is the molecular weight of the β-glucan in the cereal.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Wheat bran cereal
Wheat bran
21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.
3g high MW
Cereal containing 3g high molecular weight oat beta glucan
3g high MW
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
Cereal containing 4g oat beta glucan with medium molecular weight
4g medium MW
28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
3g medium MW
Cereal containing 3g oat beta glucan with medium molecular weight
3g medium MW
21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
4g low MW
Cereal containing 4g oat beta glucan with low molecular weight
4g low MW
28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
Interventions
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Wheat bran
21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.
3g high MW
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
28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
3g medium MW
21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
4g low MW
28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
Eligibility Criteria
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Inclusion Criteria
* no intention to lose or gain weight
* fasting total cholesterol 5.0 to 8.0 mmol/L
* fasting LDL cholesterol 3.0 to 5.0 mmol/L
* consuming diet containing \<15% energy from saturated fat
Exclusion Criteria
* regular consumption of oatmeal, oat bran or psyllium - containing cereals
* fasting serum triglycerides \>4.0mmol/L
* serum aspartate transaminase \>1.5 times upper limit of normal
* serum urea or creatinine \>1.8 times upper limit of normal
* presence of diabetes or fasting glucose \>6.9mmol/L
* presence or recent major surgical or medical event
* allergy to wheat or oats
* presence of condition or drug which alters digestion or absorption of foods
35 Years
70 Years
ALL
Yes
Sponsors
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CreaNutrition, AG
UNKNOWN
University of Guelph
OTHER
University of Sydney
OTHER
Laval University
OTHER
Reading Scientific Services Ltd.
INDUSTRY
University of Toronto
OTHER
Agriculture and Agri-Food Canada
OTHER_GOV
Glycemic Index Laboratories, Inc
INDUSTRY
Responsible Party
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Glycemic Index Laboratories, Inc.
Principal Investigators
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Thomas MS Wolever, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Glycemic Index Laboratories, Inc
Peter J Wood, PhD
Role: STUDY_DIRECTOR
Agriculture and Agri-Food Canada
Susan M Tosh, PhD
Role: STUDY_DIRECTOR
Agriculture and Agri-Food Canada
Alison L Gibbs, PhD
Role: STUDY_DIRECTOR
Department of Statistics, University of Toronto
Locations
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SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney
Sydney, New South Wales, Australia
Human Nutraceutical Research Unit, Department of Human Health and Nutritional Sciences, University of Guelph
Guelph, Ontario, Canada
Glycemic Index Laboratories, Inc.
Toronto, Ontario, 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, United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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GIL8034
Identifier Type: -
Identifier Source: org_study_id
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