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
  Purpose

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.

Condition Intervention Phase
Hypercholesterolemia
Dietary Supplement: Wheat bran
Dietary Supplement: 3g high MW
Dietary Supplement: 4g medium MW
Dietary Supplement: 3g medium MW
Dietary Supplement: 4g low MW
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Varying Dose and Molecular Weight on the Serum LDL-cholesterol-lowering Properties of Oat β-glucan

Resource links provided by NLM:


Further study details as provided by Glycemic Index Laboratories, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 367
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Wheat bran cereal
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.
Active Comparator: 3g high MW
Cereal containing 3g high molecular weight oat 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
Active Comparator: 4g medium MW
Cereal containing 4g oat beta glucan with medium 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
Active Comparator: 3g medium MW
Cereal containing 3g 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
Active Comparator: 4g low MW
Cereal containing 4g oat beta glucan with low 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

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:

  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.
  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981981

Locations
Australia, New South Wales
SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney
Sydney, New South Wales, Australia, 2006
Canada, Ontario
Human Nutraceutical Research Unit, Department of Human Health and Nutritional Sciences, University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Glycemic Index Laboratories, Inc.
Toronto, Ontario, Canada, M5C 2X3
Canada, Quebec
Nutraceuticals and Functional Foods Institute, Faculte des science de l'agriculture et de l'alimentation, Universite Laval
Laval, Quebec, Canada
United Kingdom
Reading Scientific Services, Ltd (RSSL)
Reading, Berkshire, United Kingdom, RG6 6LA
Sponsors and Collaborators
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
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas MS Wolever, President, Glycemic Index Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00981981     History of Changes
Other Study ID Numbers: GIL8034
Study First Received: September 18, 2009
Last Updated: June 20, 2011
Health Authority: Canada: Health Canada

Keywords provided by Glycemic Index Laboratories, Inc:
humans
randomized clinical trial
dietary fiber
nutrition
beta-glucan
oats
LDL cholesterol
coronary heart disease

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014