Hypercholesterolemia Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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