None listed
Conditions
Interventions
Intervention1: INDUS810 Oral Capsules: 500 mg (2 capsules of 250 mg), once daily in the
morning, before a meal (empty stomach) for 12 weeks
Control Intervention1: PLACEBO Oral Capsules: 500 mg (2 caps
Sponsors
Indus Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting the following criteria will be included in the study:1. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial 2. Women with age between 18-60 years.3.Healthy females with body mass index (BMI) of 25.0–29.9 kg/m2.4.Willing to continue with their existing diet, exercise, and lifestyle habits throughout the study without any change.5.Agree to avoid consuming any supplements meant for weight or fat loss during the study period.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Allergy or sensitivity to any ingredient of investigational product 2. Participation in any clinical study within 30 days before randomization 3. Use of natural health products/dietary supplements within 7 days before randomization and during the study 4. Pregnant or planning to be pregnant and lactating 5. Any kind of substance abuse, (alcohol, tobacco, or any other substance). 6. Participants taking cholesterol-lowering medications, e.g. Statins like atorvastatin, Fibrates like fenofibrate 7. The participant has a history of hyper or hypo thyroidism and is currently taking hyper or hypo thyroid medicines 8. Uncontrolled metabolic diseases or chronic diseases at the discretion of the investigator 9. Unstable medical conditions as determined by the qualified investigator 10. Planned surgery during the trial; history of any surgery past 3 months 11. Current diagnosis of immune-compromised conditions like HIV/AIDS and cancer 12. History of blood/bleeding disorders; blood donation in the previous 2 months 13. Any other condition that, in the qualified investigator’s opinion, may have adversely affected the participant’s ability to complete the study or its measures or which may have posed a significant risk to the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of INDUS810 oral supplementation (Capsules) on percent fat mass measured by DEXATimepoint: Baseline, Week 6, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of INDUS810 oral supplementation (capsules)on 1. Total body mass composition 2. Visceral adipose tissue (VAT) composition 3. Subcutaneous adipose tissue (SAT) composition 4. Segmental body composition 5. Total bone mineral density (BMD) 6. Resting metabolic rate (RMR) (cal/day) 7. Relative skeletal muscle mass index (RSMI) (kg/m2) 8. Anthropometric measures 9. Body mass index (BMI) 10.Fatty Liver Index (FLI) 11. Non-alcoholic fatty liver disease (NAFLD) liver fat score 12. Dose and frequency of ongoing medication to be taken for high-fat mass-related co-morbidities. 13. Liver function 14. Carbohydrate and lipid metabolism 15. Phenotypic age 16. Physical activity as measured by 6 minute walk test and 30 Second chair stand test 17. The general quality of life as measured by SF-36 questionnaire Timepoint: Baseline, Week 6, Week 12;2. To evaluate the safety of INDUS810 oral supplementation (capsules) in terms of 1. Clinical examination and vitals 2. Laboratory examinations 3. Adverse eventsTimepoint: Baseline, Week 6, Week 12 | — |
Countries
India
Contacts
Public ContactMrs Pallavi Deshpande
Indus Biotech Limited
Outcome results
None listed