Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632002
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-06
Brief Title:
Diabetes-specific Formulas on Nutritional Outcomes in Individuals With Diabetes and at Risk of Undernutrition
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Non-inferiority Trial of a New Diabetes-specific Formula Compared to an Existing Diabetes-specific Formula on Nutritional Outcomes in Individuals With Diabetes and at Risk of Undernutrition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to demonstrate the non-inferiority of diabetes-specific formula DSF1 compared to DSF2 in individuals with type 1 diabetes type 2 diabetes or prediabetes and who are at nutritional risk
Detailed Description:
This is a randomized double-blind parallel non-inferiority study Eligible participants will be randomly allocated at 11 ratio to one of two groups DSF1 experimental group or DSF2 control group Both groups will incorporate one serving of the DSF into their daily diet in addition to receiving standard of care for diabetes The total expected duration of the study is up to 104 days including a run-in period of up to 14 days followed by an intervention period of 90 days At Day 1 participants will be randomized into one of the two groups n 50 per group DSF1 or DSF2 Participants will start the intervention on Day 1 and complete the intervention on Day 90
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