Effect of replacing sugars with sweetener sucralose for 24 weeks on body weight, glycemic and lipid parameters among Overweight Asian Indian adults
- Conditions
- Health Condition 1: E663- Overweight
- Registration Number
- CTRI/2021/04/032809
- Lead Sponsor
- Zydus Wellness Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
.Overweight/ obese participants (Asian Indian specific cut off)
.Willing to follow study protocol
.Willing to give informed consent
.Willing to use LCS-sucralose for 12 weeks
.Participants with features of metabolic syndrome, pre- diabetes.
.Participants with known history or newly diagnosed diabetes
.Any acute infections like viral fever, typhoid, cold, diarrhea, constipation last 1 month
.Individuals with any disorders of liver, kidney, thyroid, or other endocrine diseases or other complications such as respiratory disorders, diabetes, cancer or heart attack and stroke that hinders the intervention
.Individuals with any eating disorder
.Participants undergoing any treatment or medications including antibiotics
.Pregnant and lactating Women
.Plans to relocate in the next 3 years.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessing the change in body weight by replacing sugar (20-30g/day) with LCS-sucralose (pellet/powder/liquid form)Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Assessing the effect of replacing sugars with low-calorie sweetener sucralose among over weight and obese adults on <br/ ><br>Glycemic parameters-Fasting glucose, glycated haemoglobin (HbA1c), fasting insulin and HOMA IR <br/ ><br>Lipid profile-serum triglyceride, HDL, LDL and VLDL cholesterol <br/ ><br>Inflammatory markers- TNF alpha and hs-CRP <br/ ><br>Advanced glycation end products (in a subsample of 50 participants) <br/ ><br>Gut microbiome (in a subsample of 50 participants)Timepoint: 12 WEEKS