None listed
Conditions
Interventions
Intervention1: Thermogenic supplement: Oral administration of a single dose of Thermogenic supplement
Control Intervention1: Placebo: Oral administration of a single dose of Placebo
Sponsors
OmniActive Health Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. BMI between 18.5 to 24.9 kg/m2 2. Subjects with normal TSH ( > 0.4 µIU/ml to 3. Subject is in good health as determined by a health and exercise status questionnaire. 4. Subject will be untrained or recreationally trained 5. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Subject has a significant history or current presence of treated or untreated bleeding disorder, metabolic (hyperlipidemia, hyperglycemia), musculoskeletal, diabetes mellitus, high blood pressure [systolic BP > 140 and/or diastolic BP > 90 mm Hg], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. 2. Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study. 3. Subject has lost =10 pounds (5 Kilograms) and maintained the weight loss or gained =10 pounds (5 Kilograms) during the previous three months. 4. Subject does not eat meals at regular intervals. 5. Subject who is habituated to very spicy food in their diet 6. Subject has a history of alcohol or other drug abuse in the past year. 7. Subject regularly uses tobacco products. 8. Subject has had an abnormal electrocardiogram. 9. Subject regularly takes any of the prohibited concomitant medications listed in the protocol. 10. Subject has a known allergy or sensitivity to any ingredient in thermogenic supplement, including caffeine. 11. Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. 12. Subject has a history of difficulty swallowing large pills or tablets. 13. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 14. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study. 15. female subjects pregnant, lactating, planning a pregnancy during the study. Female subjects 16.Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study treatment and for 4 weeks after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of of a thermogenic supplement on Energy Expenditure (EE) and Respiratory Quotient (RQ) as compared to placeboTimepoint: Day 0 (Period 1 ) and Day 7 (Period 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in VO2, VCO2 and EPOCTimepoint: Day 0 (Period 1 ) and Day 7 (Period 2) | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed