Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454773
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes A Randomized Placebo-Controlled Parallel Arm Trial
Sponsor:
Diabetes Foundation India
Organization:
Diabetes Foundation India
Study Overview
Official Title:
To Evaluate the Impact of Consumption of Bioactive Compounds Extracted From Hemp Hull and Black Pepper on Fasting Blood Glucose Levels in People With Pre-diabetes A Randomized Placebo-Controlled Parallel Arm Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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 controlled 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:
To study the impact of bioactive compound supplementation on fasting blood glucose
To study the impact of intervention with bioactive compound on following measures of glycaemia
24 hr AUC total from CGM Post-prandial glucose regulation
iAUC determined from CGM readout up to 2 hr after consumption of a Standard Meal Blood Chemistry
Fasting Insulin
HbA1c
Lipid profile Anthropometry
Weight
BMI
Waist Circumference
To study the impact of intervention with bioactive compound on following measures of glycaemia
24 hr AUC total from CGM Post-prandial glucose regulation
iAUC determined from CGM readout up to 2 hr after consumption of a Standard Meal Blood Chemistry
Fasting Insulin
HbA1c
Lipid profile Anthropometry
Weight
BMI
Waist Circumference
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