Assessing the impact of incorporating unripe jackfruit recipe in diet on glycemic parameters and cardiovascular risk factors.
Phase 4
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2024/01/061797
- Lead Sponsor
- State Board of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Newly diagnosed or follow up patients with T2DM with poor glycemic
control (HbA1C > 7.5 % or FPG >150 mg/dl or PPPG >200 mg/dl), Patient having a pre-
enrolment dietary caloric intake not exceeding 20% of his recommended caloric intake and age
18 to 70 years.
Exclusion Criteria
Patients with dyspepsia,diarrhoea, critically ill patients, Patients who
has intolerance to Jackfruit products, Patients on insulin or other injectable antidiabetic
agent,Patients with known structural or rhythm diseases of heart, Patients withcomplications of
diabetes like nephropathy, retinopathy, patients with verypoor glycemic control {HbA1C more
than 10}.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of partial substitution of diet with unripe Jackfruit basedrecipe on glycemic <br/ ><br>control as assessed by fasting plasma glucose, postprandial plasma glucose, and HbA1C in <br/ ><br>poorly controlled diabetic patients.Timepoint: 22nd day and 91st day
- Secondary Outcome Measures
Name Time Method To find the effect of unripe jackfruit intake on other cardiovascular risk variables like blood <br/ ><br>pressure, Body Mass Index (BMI), waist –hip ratio and lipid profileTimepoint: 22nd day and 91st day