Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417840
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-13
Brief Title:
To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes
Sponsor:
Brightseed
Organization:
Brightseed
Study Overview
Official Title:
To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes A Randomized Double Blinded Placebo-controlled Parallel Arm Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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 is randomized placebo controlled double-blinded parallel arm study on free living Asian Indians Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime At the end of the run-in period subjects fulfilling the inclusionexclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables
The measured parameters will include 24-h diet recall food frequency questionnaire anthropometry including circumferences height and weight and blood parameters including blood glucose fasting serum insulin fasting HbA1c and lipid profile
The measured parameters will include 24-h diet recall food frequency questionnaire anthropometry including circumferences height and weight and blood parameters including blood glucose fasting serum insulin fasting HbA1c and lipid profile
Detailed Description:
None
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