Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol (Bluebird)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Wheat bran
3g high MW
4g medium MW
3g medium MW
4g low MW
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring humans, randomized clinical trial, dietary fiber, nutrition, beta-glucan, oats, LDL cholesterol, coronary heart disease
Eligibility Criteria
Inclusion Criteria:
- body mass index 18.5 to 40.0 kg/m^2
- 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:
- use of any cholesterol-lowering drug, herbal or nutritional supplement
- 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
Sites / Locations
- SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney
- Human Nutraceutical Research Unit, Department of Human Health and Nutritional Sciences, University of Guelph
- Glycemic Index Laboratories, Inc.
- Nutraceuticals and Functional Foods Institute, Faculte des science de l'agriculture et de l'alimentation, Universite Laval
- Reading Scientific Services, Ltd (RSSL)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control
3g high MW
4g medium MW
3g medium MW
4g low MW
Arm Description
Wheat bran cereal
Cereal containing 3g high molecular weight oat beta glucan
Cereal containing 4g oat beta glucan with medium molecular weight
Cereal containing 3g oat beta glucan with medium molecular weight
Cereal containing 4g oat beta glucan with low molecular weight
Outcomes
Primary Outcome Measures
Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan
Correlation between serum LDL-cholesterol lowering and log(MW*C)
Secondary Outcome Measures
Total cholesterol
Serum triglycerides
Serum HDL cholesterol
Fasting serum glucose
Serum aspartate transaminase
serum c-reactive protein
Serum urea
Serum creatinine
Time course of changes in blood lipids
Blood pressure
Macronutrient composition of diet
Symptoms questionnaire
apolipoprotein B
Serum markers of cholesterol absorption and synthesis
Full Information
NCT ID
NCT00981981
First Posted
September 18, 2009
Last Updated
June 20, 2011
Sponsor
Glycemic Index Laboratories, Inc
Collaborators
CreaNutrition, AG, University of Guelph, University of Sydney, Laval University, Reading Scientific Services Ltd., University of Toronto, Agriculture and Agri-Food Canada
1. Study Identification
Unique Protocol Identification Number
NCT00981981
Brief Title
Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol
Acronym
Bluebird
Official Title
Effect of Varying Dose and Molecular Weight on the Serum LDL-cholesterol-lowering Properties of Oat β-glucan
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Glycemic Index Laboratories, Inc
Collaborators
CreaNutrition, AG, University of Guelph, University of Sydney, Laval University, Reading Scientific Services Ltd., University of Toronto, Agriculture and Agri-Food Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purposes of this study were:
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.
To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced when the molecular weight of the fiber was reduced.
Detailed Description
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:
An extruded oat cereal containing 3g high-molecular weight oat β-glucan daily will reduce LDL cholesterol compared to a control wheat bran cereal.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
humans, randomized clinical trial, dietary fiber, nutrition, beta-glucan, oats, LDL cholesterol, coronary heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Wheat bran cereal
Arm Title
3g high MW
Arm Type
Active Comparator
Arm Description
Cereal containing 3g high molecular weight oat beta glucan
Arm Title
4g medium MW
Arm Type
Active Comparator
Arm Description
Cereal containing 4g oat beta glucan with medium molecular weight
Arm Title
3g medium MW
Arm Type
Active Comparator
Arm Description
Cereal containing 3g oat beta glucan with medium molecular weight
Arm Title
4g low MW
Arm Type
Active Comparator
Arm Description
Cereal containing 4g oat beta glucan with low molecular weight
Intervention Type
Dietary Supplement
Intervention Name(s)
Wheat bran
Intervention Description
21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.
Intervention Type
Dietary Supplement
Intervention Name(s)
3g high MW
Intervention Description
20.2 grams per day of ready to eat cereal containing 6g total dietary fiber and 3g oat beta glucan with high molecular weight
Intervention Type
Dietary Supplement
Intervention Name(s)
4g medium MW
Intervention Description
28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
Intervention Type
Dietary Supplement
Intervention Name(s)
3g medium MW
Intervention Description
21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
Intervention Type
Dietary Supplement
Intervention Name(s)
4g low MW
Intervention Description
28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
Primary Outcome Measure Information:
Title
Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan
Time Frame
4 weeks
Title
Correlation between serum LDL-cholesterol lowering and log(MW*C)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol
Time Frame
4 weeks
Title
Serum triglycerides
Time Frame
4 weeks
Title
Serum HDL cholesterol
Time Frame
4 weeks
Title
Fasting serum glucose
Time Frame
4 weeks
Title
Serum aspartate transaminase
Time Frame
4 weeks
Title
serum c-reactive protein
Time Frame
4 weeks
Title
Serum urea
Time Frame
4 weeks
Title
Serum creatinine
Time Frame
4 weeks
Title
Time course of changes in blood lipids
Time Frame
4 weeks
Title
Blood pressure
Time Frame
4 weeks
Title
Macronutrient composition of diet
Time Frame
4 weeks
Title
Symptoms questionnaire
Time Frame
4 weeks
Title
apolipoprotein B
Time Frame
4 weeks
Title
Serum markers of cholesterol absorption and synthesis
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
body mass index 18.5 to 40.0 kg/m^2
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:
use of any cholesterol-lowering drug, herbal or nutritional supplement
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas MS Wolever, MD, PhD
Organizational Affiliation
Glycemic Index Laboratories, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter J Wood, PhD
Organizational Affiliation
Agriculture and Agri-Food Canada
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susan M Tosh, PhD
Organizational Affiliation
Agriculture and Agri-Food Canada
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alison L Gibbs, PhD
Organizational Affiliation
Department of Statistics, University of Toronto
Official's Role
Study Director
Facility Information:
Facility Name
SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia
Facility Name
Human Nutraceutical Research Unit, Department of Human Health and Nutritional Sciences, University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada
Facility Name
Glycemic Index Laboratories, Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2X3
Country
Canada
Facility Name
Nutraceuticals and Functional Foods Institute, Faculte des science de l'agriculture et de l'alimentation, Universite Laval
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Reading Scientific Services, Ltd (RSSL)
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6LA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20660224
Citation
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.
Results Reference
result
PubMed Identifier
20527967
Citation
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.
Results Reference
result
PubMed Identifier
22118569
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol
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