A study to evaluate the effect of orlistat + resveratrol combination on weight management

Not Applicable

• Conditions: Obesity and overweight; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN10642495
• Lead Sponsor: Zydus Lifesciences Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-04
• Last Update Posted: 12 September 2022
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 264

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% 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.