Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03805802
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2019-01-13
Brief Title:
Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Sponsor:
Stoffwechselzentrum Rhein - Pfalz
Organization:
Stoffwechselzentrum Rhein - Pfalz
Study Overview
Official Title:
Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber After the first 6 weeks both groups will be switched to the high fiber product
Detailed Description:
It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes In addition previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes Recent clinical data indicates that early hyperglycemia can be normalized by a diet high in fiber In this controlled pilot study a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach hereafter all participants will be switched to the oat bran product The primary endpoint will be fasting glucose after 6 weeks Secondary endpoints will be long-term glucose control as measured by HbA1c self-documented glucose as well as the body weight and body mass index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None