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Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol (Bluebird)

This study has been completed.
Sponsor:
Collaborators:
CreaNutrition, AG
University of Guelph
University of Sydney
Laval University
Reading Scientific Services Ltd.
University of Toronto
Agriculture and Agri-Food Canada
Information provided by:
Glycemic Index Laboratories, Inc
ClinicalTrials.gov Identifier:
NCT00981981
First received: September 18, 2009
Last updated: June 20, 2011
Last verified: June 2011
History of Changes

September 18, 2009
June 20, 2011
November 2008
July 2009   (final data collection date for primary outcome measure)
  • Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Correlation between serum LDL-cholesterol lowering and log(MW*C) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00981981 on ClinicalTrials.gov Archive Site
  • Total cholesterol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum triglycerides [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum HDL cholesterol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Fasting serum glucose [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum aspartate transaminase [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • serum c-reactive protein [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum urea [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Time course of changes in blood lipids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Macronutrient composition of diet [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Symptoms questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • apolipoprotein B [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum markers of cholesterol absorption and synthesis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol
Effect of Varying Dose and Molecular Weight on the Serum LDL-cholesterol-lowering Properties of Oat β-glucan

The purposes of this study were:

  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.

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:

  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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Dietary Supplement: 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.
  • Dietary Supplement: 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
  • Dietary Supplement: 4g medium MW
    28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
  • Dietary Supplement: 3g medium MW
    21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
  • Dietary Supplement: 4g low MW
    28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
  • Placebo Comparator: Control
    Wheat bran cereal
    Intervention: Dietary Supplement: Wheat bran
  • Active Comparator: 3g high MW
    Cereal containing 3g high molecular weight oat beta glucan
    Intervention: Dietary Supplement: 3g high MW
  • Active Comparator: 4g medium MW
    Cereal containing 4g oat beta glucan with medium molecular weight
    Intervention: Dietary Supplement: 4g medium MW
  • Active Comparator: 3g medium MW
    Cereal containing 3g oat beta glucan with medium molecular weight
    Intervention: Dietary Supplement: 3g medium MW
  • Active Comparator: 4g low MW
    Cereal containing 4g oat beta glucan with low molecular weight
    Intervention: Dietary Supplement: 4g low MW

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
August 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   United Kingdom
 
NCT00981981
GIL8034
No
Thomas MS Wolever, President, Glycemic Index Laboratories, Inc.
Glycemic Index Laboratories, Inc
  • CreaNutrition, AG
  • University of Guelph
  • University of Sydney
  • Laval University
  • Reading Scientific Services Ltd.
  • University of Toronto
  • Agriculture and Agri-Food Canada
Principal Investigator: Thomas MS Wolever, MD, PhD Glycemic Index Laboratories, Inc
Study Director: 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
Glycemic Index Laboratories, Inc
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP