Ignite Creation Date:
2024-05-05 @ 9:52 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00981981
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2009-09-18
Brief Title:
Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol
Sponsor:
Glycemic Index Laboratories Inc
Organization:
Glycemic Index Laboratories Inc
Study Overview
Official Title:
Effect of Varying Dose and Molecular Weight on the Serum LDL-cholesterol-lowering Properties of Oat β-glucan
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bluebird
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 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
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
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 logCMW 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
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 logCMW 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None