Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Low calorie sweetener-Sucralose (in either pellet or powder or liquid form): LCS-Sucralose (in either pellet or powder or liquid form) will be given to study
participants to be used in
Sponsors
Zydus Wellness Ltd
Eligibility
Inclusion criteria
Inclusion criteria: .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.
Exclusion criteria
Exclusion criteria: .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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the change in body weight by replacing sugar (20-30g/day) with LCS-sucralose (pellet/powder/liquid form)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessing the effect of replacing sugars with low-calorie sweetener sucralose among over weight and obese adults on Glycemic parameters-Fasting glucose, glycated haemoglobin (HbA1c), fasting insulin and HOMA IR Lipid profile-serum triglyceride, HDL, LDL and VLDL cholesterol Inflammatory markers- TNF alpha and hs-CRP Advanced glycation end products (in a subsample of 50 participants) Gut microbiome (in a subsample of 50 participants)Timepoint: 12 WEEKS | — |
Countries
India
Contacts
Public ContactMrs Sudha Vasudevan
Madras Diabetes Research Foundation
Outcome results
None listed