Health Condition 1: null- High fat mass Health Condition 2: E663- Overweight
Conditions
Interventions
Intervention1: Standardized fenugreek extract: Capsules (300mg, one capsule, twice a day)for 8 weeks
Control Intervention1: Placebo: Capsules (300mg, one capsule, twice a day)for 8 weeks
Sponsors
Indus Biotech Private Limited Pune
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent from the subject • Male or female • Age 18-35 years inclusive • Body fat mass measured by skin fold thickness >25% for males and >30% for females
Exclusion criteria
Exclusion criteria: • Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion. • Subject has an elevated resting heart rate ( >100 bpm) or blood pressure (SBP more than or equal to 140 or DBP more than or equal to 90 mm Hg). • SGOT and SGPT more than or equal to 2 times the upper limit of normal • Serum creatinine more than or equal to 2 times the upper limit of normal • Hemoglobin • Subject has a history of medical or surgical events that may affect the study outcome or place the subject at risk, including cardiovascular disease, gastrointestinal problems, metabolic (including but not limiting to diabetes), renal, hepatic, neurological or active musculoskeletal disorders. • Subject has a history of orthopedic injury or surgery, which can interfere in activity schedule. • Known hypersensitivity to herbal drugs/nutritional supplement/ foods • Postmenopausal females • Subjects who is consuming/ has received any antiobesity or fat reducing therapy during last 2 months • Subjects who is consuming/ has received any performance enhancing medication. • Subjects undergoing any additional weight loss or diet plan during the trial period • Chronic alcoholics • Drug abusers • Pregnant, willing to get pregnant or not ready to use contraceptive measures during the study period • Participation in any other clinical trial during last 30 days • Simultaneous participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in % and absolute fat mass (measured on the basis of skin fold thickness) after 4 and 8 weeksTimepoint: At screening, 4th week and 8th week | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change from baseline in % and absolute non fat mass (measured on the basis of skin fold thickness) after 4 and 8 weeks â?¢ Change from baseline in Body weight and BMI after 4 and 8 weeks â?¢ Change from baseline in abdominal girth after 4 and 8 weeks â?¢ Change from baseline in absolute skin fold thickness after 4 and 8 weeks â?¢ Change from baseline in body fat and non fat mass (measured by BIA) after 4 and 8 weeks Timepoint: At screening, 4th week and 8th week | — |
Countries
India
Contacts
Public ContactDr Prasad Thakurdesai
Indus Biotech Private Limited
Outcome results
None listed