Effect of debittered and defatted fenugreek flakes on 24 hour blood glucose levels among adults with type 2 diabetes
Phase 1
Completed
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/08/020654
- Lead Sponsor
- Indus Biotech PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
Inclusion Criteria
Adults with known diabetes
Not on insulin treatment
BMI <18.5kg/ m2 - >30kg/ m2
HbA1c between 7% to 11%
On stable anti-hypertensive and lipid lower medication
Volunteers willing to give informed consent
Exclusion Criteria
Type 1 diabetes subjects
Females who are pregnant, lactating or planning to become pregnant
Known food or drug allergy
Subjects with any eating disorder or lactose intolerance
chronic disease of heart, liver, kidney.
Subject participating simultaneously or 3 months prior to screening in any other clinical trial.
Subjects who are already consuming Fenugreek in soaked or powder form on daily basis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in 24 hour incremental area under the blood glucose curve for 14 days assessed using flash glucose monitoringTimepoint: baseline (day 1) and End (Day 14) for each randomized diet.
- Secondary Outcome Measures
Name Time Method To assess the changes in fasting blood glucose, insulin, and HbA1c from baseline. <br/ ><br>To determine changes in body weight from baseline <br/ ><br>Timepoint: baseline (day 1) and End (Day 14) for each randomized diet.