A clinical saftey and efficacy trial of Sugarlite a marketeted product on Healthy lifestyle modificatio
- Registration Number
- CTRI/2021/02/030921
- Lead Sponsor
- Zydus Wellness
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•Subjects of both sexes in the age group of 18 - 45 years
•Normal to Pre obese subjects (BMI â?? 23.00kg/M2 to 26 kg/M2)
•Subjects willing to give written informed consent.
•Those who agree to follow the general guidelines on diet, sugar intake and exercise.
•Subjects who have not participated in similar kind of study in last 4 weeks.
•Subjects with established hypertension, renal, hepatic or cardiac failure
•Endocrine disorders like Hypothyroid ( if already on treatment)
•Subjects with Dyslipidemia or Inborn errors of Fat metabolism.
•Subjects with Postprandial sugars above 150 mg /dl in two tests so can be labelled
Early Diabetic
•History of drug hyper sensitivity or allergic condition that might interfere with the study
•Use of drugs or dietary supplements that might influence body weight, body fat, or serum lipid levels like Anti diabetic drugs like Metformin and Statins.
•Pregnant & lactating women.
•Not willing to sign informed consent form.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight , BMI , Blood glucose and Lipid ParametersTimepoint: Baseline , 30 days , 60 days and 90 days
- Secondary Outcome Measures
Name Time Method Blood cholesterol , Trigycerides, random bllod sugar and Hba1 C valuesTimepoint: Once every month for 3 months after baseline values