Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Sugar Free Green: Subject will be instructed to use the test product instead of their routine sugar. The test product is equivalent to one teaspoon of sugar in sweetness.
One pellet of
Sponsors
Zydus Wellness Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 55 yrs 2) Sex: Male and/or non-pregnant/ non-lactating females 3) Body Mass Index (BMI) of >=25 to 4) For Pre-diabetics subjects: Fasting Blood Glucose level from 100-125 mg/dL (called impaired fasting glucose or IFG) and HbA1c levels >=5.7% to 5) Subjects willing to follow diet plan 6) Subjects willing to reduce their weight and waist circumference 7) Subjects with history of stable weight, defined as no significant weight change (less than ±5%) within 03 months prior to enrollment and the physical activity level lesser than 2.0 8) Normal renal and liver tests 9) Subject must be willing to abstain to eat any other sugar containing products, any other form of sugar usage for the duration of the study
Exclusion criteria
Exclusion criteria: 1) Pregnant female subjects or females planning to get pregnant during study duration 2) Subjects having Type 1/ Type 2 Diabetes Mellitus 3) Subjects having Insulin Resistance 4) Subjects having Lipid Abnormalities 5) Subject diagnosed with eating disorders such as bulimia or binge eating 6) History of Positive HIV test 7) History of Hepatitis B Virus 8) Subject with any history of drug and alcohol abuse 9) History of Cancer 10) History of clinically significant cardiac disease or endocrine abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effect of test product will be measured in terms of change in body weight from baseline 2. Effect of test product will be measured in terms of change in waist circumference from baselineTimepoint: On Day 30, Day 60 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of test product will be assessed in terms of reduction in HbA1c from baselineTimepoint: On Day 30, Day 60 and Day 90.;Effect of test product will be assessed in terms of reduction in lipid profile along with lipoprotein levels from baselineTimepoint: On Day 30, Day 60 and Day 90;Effect of test product will be assessed in terms of Satiety level of the subjects based on subjectsâ?? feedback from BaselineTimepoint: On Day 30, Day 60 and Day 90;Safety of the test product in terms of adverse events reported by subjects or assessed by Investigator during study.Timepoint: On Day 30, Day 60 and Day 90;Safety of the test product will be assessed in terms of adverse events reported by subjects or assessed by Investigator.Timepoint: On Day 30, Day 60 and Day 90.;To assess the amount of sugar consumption of subjects based on subjective evaluation on baselineTimepoint: On Day 30, Day 60 and Day 90 | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed