Randomized control trial to assess the effect of peanut intake daily for 12 weeks on cardio metabolic risk reduction.
- Registration Number
- CTRI/2023/12/060479
- Lead Sponsor
- Madras Diabetes Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Participants who are overweight and obese
Age group 30 to 65 yrs, both males and females
Willing to follow study protocol
Willing to give informed consent
BMI less than 22.9 kg/m2
On insulin injections
Any acute infections like viral fever, typhoid,
cold, diarrhea, constipation last 1 month
Having diabetes, diabetes induced/related
complications [nephropathy, retinopathy]-
thyroid dysfunction, respiratory disorders,
cancer or heart attack and stroke,
Having any eating disorder or lactose
intolerance
Taking any herbal/Ayurvedic/traditional
preparation/nutrition supplements that could
profoundly affect blood glucose
Pregnant and lactating Women
Plans to relocate in the next 2 years.
Planning longer duration of travel out of town
Enrolled in any other clinical trials
Participated in a clinical study in the last 3
months
Employee of the site conducting the study.
Participants with habitual abuse (Alcohol,
smoking, tobacco) substance consumption
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of peanut administered <br/ ><br>for 12 weeks on markers of glycemic- HbA1c, fasting and post glucose, dyslipidemia-total cholesterol, HDL,LDL and triglyceride levels, body composition-weight, body mass index and waist circumference and inflammatory markers <br/ ><br>as compared to control group.Timepoint: Blood samples will be collected at 2 time points baseline and end of 12 weeks study period. Inaddition participant will be contacted by the research team monthly once for anthropometric, clinical and dietary assessments.
- Secondary Outcome Measures
Name Time Method Examine peanut supplementation will have beneficial effects on measures of cognition, sleep quality and mood as compared to control group.Timepoint: 2 time points baseline and end of 12 weeks study period.