Efficacy of novel blended diet (BE22001) compared with conventional diet in improving the well-being of healthy adults
- Registration Number
- CTRI/2022/10/046112
- Lead Sponsor
- B2E Foods Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Healthy male and female subjects aged between 35-60 years with a Body Mass Index-BMI of 25-29.9 kg per metre square.
2.Subject agrees to consume provided vegetarian diet for four months approximately 1800 k.cal per day for Women and 2000 k.cal per day for Men as per dietician.
3.Subjects who agree to consume 3 meal patterns per day-breakfast, lunch and dinner for entire study duration.
4.Subject agrees not to fast during the study period.
5.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
6.Subject agrees not to use supplements, herbals, vitamins, any therapies that affect the study outcomes during the entire course of study.
7.Willing to sign written informed consent and comply with study protocol.
1.Subjects underwent treatment for COVID-19 within last three months or tested positive during the study will be excluded.
2.Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, pagets disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
3.Subjects having history of asthma and cardiovascular diseases.
4.Subjects who use any medicines or supplements for diabetic and or hypertension or hyperlipidemia.
5.Subjects having history of thyroid disease and coagulopathies.
6.Subjects having any significant findings in the laboratory test during screening as per PI discretion.
7.Subjects with HIV Positive.
8.Subjects having history of high alcohol intake greater than 2 standard drinks per day.
9.Females who are pregnant, breast feeding or planning to become pregnant during the study.
10.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
11.Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
12.Subjects with known allergy to any of the dietary ingredients.
13.Subjects participated in any investigational study 30 days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to the end of the study period in: <br/ ><br>Triglyceride-Glucose Index (TyG Index) <br/ ><br>Timepoint: Day 1, Day 30, Day 70 and Day 120 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method