Health Condition 1: null- Obesity
Conditions
Interventions
Intervention1: Forskolin(25mg): Oral dose of two capsules twice daily for 84 days
Intervention2: Forskolin+Turmerone(50mg): Two capsules twice daily
Intervention3: Forskolin + Turmerone (100 mg): Two
Sponsors
Sabinsa Corporation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects ranging in age from 18 to 55 years 2. BMI range 30 to 36 3. Willingness to follow the protocol requirement as evidenced by written, informed consent. 4. Willingness to follow strict diet control as advised by the dietician. 5. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study. 6. Subjects with normal gastrointestinal digestion and absorption 7. All female subjects must have a negative urine pregnancy test prior to entry into the study. All females who are of child bearing potential or those within the first two years of the onset of menopausal symptoms must be using acceptable methods of birth control. (Barrier methods are acceptable birth control methods,i.e.diaphragm / condom with spermicide. Unacceptable method include: oral or implanted contraceptives).
Exclusion criteria
Exclusion criteria: 1. Require any medication for a chronic condition. 2. Change in weight of 5 kilograms within 3 months 3. Significant abnormal findings as determined by baseline history, physical examination. 4. History or presence of significant alcoholism or drug abuse in the past one year. 5. Any medical or surgical conditions, which might significantly, interfere with the gastrointestinal tract, liver, kidneys, and/or blood ? forming organs. 6. History of cardiovascular, renal, hepatic, asthma, glaucoma, pulmonary, neurologic, metabolic or psychiatric disease. 7. Systolic blood pressure 140 or diastolic blood pressure 90 8. Participation in a clinical study during the preceding 90 days. 9. History of malignancy or other serious disease. 10. Any contraindication to blood sampling. 11. Smoking or Consumption of tobacco products. 12. Use of alcohol or xanthine (caffeine)-containing beverages or food for 48 hours prior to each supplement dose. 13. Blood or blood products donated in past 30 days prior to study supplement administration. 14. In case of female subjects pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Absolute change in body weight from baseline to final. 2) Change in Body Mass IndexTimepoint: 1,21,42,63,84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1] Change in anthropometric measurements 2] Significant changes in laboratory parameters 3] All treatment-emergent adverse events occurring during the treatment periodTimepoint: 1,21,42,63,84 days | — |
Countries
India
Contacts
Public ContactMadhuri Bangera
Outcome results
None listed