Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Test diet (Isocaloric diet with Debittered and defatted fenugreek flakes): Iso caloric rice based diet with debittered defatted fenugreek flakes for 14 days.
Control Intervention1: Cont
Sponsors
Indus Biotech PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: Adults with known diabetes Not on insulin treatment BMI 30kg/ m2 HbA1c between 7% to 11% On stable anti-hypertensive and lipid lower medication Volunteers willing to give informed consent
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the changes in fasting blood glucose, insulin, and HbA1c from baseline. To determine changes in body weight from baseline Timepoint: baseline (day 1) and End (Day 14) for each randomized diet. | — |
Countries
India
Contacts
Public ContactSudha Vasudevan
Madras Diabetes Research Foundation
Outcome results
None listed