None listed
Conditions
Interventions
Intervention1: Capsimax: 100 mg capusle once a day for 7 days
Control Intervention1: Placebo: 100 mg capusle once a day for 7 days
Sponsors
OmniActive Health Technologies, India
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must have a BMI of 18.5 to 29.9 kg/m2 (both limits inclusive).Subjects must have greater than one year of resistance training experience at a frequency of 2 days per week.Subjects must be familiar with the barbell back squat exercise.Subjects must be free of any physical limitations or chronic illness that may affect performance.Subjects must be free of any medications.Subjects who agree to refrain from consuming alcohol 24 hours prior to the visit days.Subjects who agreed to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.Subject willing to provide written consent.Subjects willing to refrain from vigorous physical activity/ strenuous exercise 24 hours prior to test days.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion criteria
Exclusion criteria: Subjects having hypersensitivity or history of allergy to the study product.Subjects with uncontrolled hypertension (SBP greather than 160 mmHg or DBP greater than 100 mmHg) at screening.Subjects with a malignant disease or any concomitant end-state organ disease and or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition)and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.Subjects with inability to swallow soft gel capsules.Subjects who require medications.Subjects who regularly use a dietary supplement containing Capsimax or other ingredients that would impact study endpoints.Subjects with a history of drug and or alcohol abuse at the time of enrolment.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in efficacy parameters of Peak power and rate of force development during an isometric strength test,performance during the barbell back squat exercise protocol and performance during the push-up protocol.Timepoint: Baseline, Day 7, Day 15 and Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Velocity related measure and Resting energy expenditure. Timepoint: Baseline, Day 7, Day 15 and Day 21;Mean change in Nitric oxide bioavailability and skeletal muscle oxygenation Timepoint: Baseline, Day 7, Day 15 and Day 21;Mean change in Agility and reaction time Timepoint: Baseline, Day 7, Day 15 and Day 21;Mean change in VAS for feelings of fatigue and pain and Rating of perceived exertionTimepoint: Baseline, Day 7, Day 15 and Day 21;Mean change in Glucagon-like peptide-1Timepoint: Baseline, Day 7 and Day 21;Overall safetyTimepoint: Baseline, Day 7, Day 15 and Day 21 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed