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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
367
21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.
20.2 grams per day of ready to eat cereal containing 6g total dietary fiber and 3g oat beta glucan with high molecular weight
28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
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
Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan
Time frame: 4 weeks
Correlation between serum LDL-cholesterol lowering and log(MW*C)
Time frame: 4 weeks
Total cholesterol
Time frame: 4 weeks
Serum triglycerides
Time frame: 4 weeks
Serum HDL cholesterol
Time frame: 4 weeks
Fasting serum glucose
Time frame: 4 weeks
Serum aspartate transaminase
Time frame: 4 weeks
serum c-reactive protein
Time frame: 4 weeks
Serum urea
Time frame: 4 weeks
Serum creatinine
Time frame: 4 weeks
Time course of changes in blood lipids
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Macronutrient composition of diet
Time frame: 4 weeks
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21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
Laval, Quebec, Canada
Reading Scientific Services, Ltd (RSSL)
Reading, Berkshire, United Kingdom
Symptoms questionnaire
Time frame: 4 weeks
apolipoprotein B
Time frame: 4 weeks
Serum markers of cholesterol absorption and synthesis
Time frame: 4 weeks