Status:
COMPLETED
Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol
Lead Sponsor:
Glycemic Index Laboratories, Inc
Collaborating Sponsors:
CreaNutrition, AG
University of Guelph
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
35-70 years
Phase:
PHASE2
Brief Summary
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" ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00981981
Start Date
November 1 2008
End Date
August 1 2009
Last Update
June 21 2011
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney
Sydney, New South Wales, Australia, 2006
2
Human Nutraceutical Research Unit, Department of Human Health and Nutritional Sciences, University of Guelph
Guelph, Ontario, Canada, N1G 2W1
3
Glycemic Index Laboratories, Inc.
Toronto, Ontario, Canada, M5C 2X3
4
Nutraceuticals and Functional Foods Institute, Faculte des science de l'agriculture et de l'alimentation, Universite Laval
Laval, Quebec, Canada