Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01495052
Status:
COMPLETED
Last Update Posted:
2011-12-19
First Post:
2011-12-09
Brief Title:
Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus
Sponsor:
Yong Li
Organization:
Peking University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-12
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:
Dietary modification is of great essential for the prevention and treatment of type 2 diabetes mellitus Common oat Avena sativa L and its products showed a great potential benefits on NCDs including type 2 diabetes mellitus But data about such effects of naked oat Avena nuda L is still unavailable The investigators aimed to examine the effects of organic naked oat with whole germ ONOG plus diet on patients with type 2 diabetes
After a pre-study with healthy adults a randomized single-blinded multi-arm parallel trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes Participants would be randomly assigned to one of the four following groups usual care group only basic health advice no other interventions diet group systematic education structured dietary 50g-ONOG plus diet group all the interventions of diet group plus replacement of 50g ONOG per day and 100g-ONOG plus diet group A regular follow-up for years would be carried out to predict the long-term effects of ONOG plus diet intervention on patients with type 2 diabetes
The investigators hypothesized that ONOG combined with diet would have better effects on glycaemia and insulin resistance control in addition to those yielded by diet or usual care
After a pre-study with healthy adults a randomized single-blinded multi-arm parallel trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes Participants would be randomly assigned to one of the four following groups usual care group only basic health advice no other interventions diet group systematic education structured dietary 50g-ONOG plus diet group all the interventions of diet group plus replacement of 50g ONOG per day and 100g-ONOG plus diet group A regular follow-up for years would be carried out to predict the long-term effects of ONOG plus diet intervention on patients with type 2 diabetes
The investigators hypothesized that ONOG combined with diet would have better effects on glycaemia and insulin resistance control in addition to those yielded by diet or usual care
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ONOG-0001-01 | OTHER | Beijing Nutrition society | None |