Obesity and overweight Nutritional, Metabolic, Endocrine
Conditions
Interventions
Randomization: online tool for random sequence generation
Control arm: orlistat 120 mg hard capsules thrice daily
Test arm: orlistat 120 mg + resveratrol 100 mg hard c
Sponsors
Zydus Lifesciences Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex (male or female) having age =18 years 2. Subjects with a BMI =25 kg/m² (overweight or obese) with or without metabolic syndrome (or components of metabolic syndrome like hypertension, type 2 diabetes, dyslipidemia or fatty liver) and prescribed orlistat or orlistat+resveratrol by their treating physician 3. Subjects and/or their legal guardian able to provide written informed consent and willing to comply with physician’s instructions
Exclusion criteria
Exclusion criteria: 1. Subjects receiving orlistat other than Zytrim or Zytrim-R 2. Any contraindication for orlistat or orlistat + resveratrol as per the prescribing information 3. Subject simultaneously participating in any other clinical studies or having participated in any other clinical trial in the past 3 months (except survey-based studies) 4. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV infection, or coronary artery disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of patients achieving more than or equal to 5% weight loss as compared to baseline. Weight will be measured using a digital weighing scale at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in weight (? kg) measured using a digital weighing scale at baseline and 12 weeks 2. Skin fold thickness measured using a calliper at baseline and 12 weeks 3. Waist circumference measured using a measuring tape at baseline and 12 weeks 4. Body Mass Index (BMI) measured using the TANITA device at baseline and 12 weeks 5. Skeletal muscle mass, bone mass, visceral and total body fat measured using the TANITA device at baseline and 12 weeks 6. Daily caloric intake, metabolic age, and total body water measured using the TANITA device at baseline and 12 weeks 7. Resting blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured using a digital blood pressure monitor at baseline and 12 weeks 8. Lipid profile (minimum parameters LDL, HDL, TG and Total Cholesterol), HbA1c and liver function tests (AST and ALT) measured using a blood test at baseline and 12 weeks 9. Liver fat measured using FIBROSCAN at baseline and 12 weeks | — |
Countries
Myanmar
Outcome results
None listed