Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT03805802
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2019-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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:
False
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?: