None listed
Conditions
Interventions
Intervention1: Oxystrom: In each session, Oxystorm 2000 mg mixed with 250 ml of water 90 minutes before the exercise bout
Control Intervention1: Placebo: In each session, Placebo 2000 mg mixed with 25
Sponsors
Arjuna Natural Extracts Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject has a B.W in between 45 to 75 kg. 2. Subject is a non-smoker. 3. Subject is in good health and appropriate for exercise. 4. Subject agrees to not use any new vitamins and/or minerals until after study completion and to not take any vitamins and/or minerals 24 hours prior to the test visits. 5. Subject agrees to not use any dietary or herbal supplements until after study completion. A 7-day washout is allowed for study inclusion. 6. Subject is willing and able to comply with the protocol including: Attending 4 visits each of which is approximately 3 hours long; Refraining from caffeine, over-the-counter medications and alcohol for the 24 hours prior to the test visits; Refraining from physical training or exercise for the 48 hours prior to the test visits; Refraining from taking any dietary or herbal supplements throughout the study. 7. Subject is able to understand and sign the informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: The subjects will be excluded based on the following criteria during screening and during the study. 1. Subjects with or prior history or presence of clinically significant Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 2. Subject has any orthopedic problem(s) or history of musculoskeletal injury(ies) which make(s) resistance weight training contraindicated. 3. Subject has a history of cancer (except localized skin cancer without metastases) within 5 years prior to screening. 4. No prescription or chronic medication use allowed without PI discretion. 5. Subject has an allergy to any of the ingredients in the test product. 6. Subject is currently taking and unwilling to refrain from taking any over-the-counter stimulant medications/ supplements; seven-day washout required for study inclusion. 7. Subject is currently taking and unwilling to refrain from taking any over-the-counter allergy or asthma medication containing pseudoephedrine or ephedrine; seven-day washout required for study inclusion. 8. Subject reports being a regular caffeine consumer defined as consuming > 600 mg of caffeine per day. 9. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the physical examination. 10. Subject has a history of drug or alcohol abuse in the past 12 months. 11. Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Change from Baseline in Rate of oxygen consumption VO2max (Endurance) compared to placebo. B. Change from Baseline in Rate Perceived Exertion compared to placebo. C. Change from Baseline in Exercise Self efficacy compared to placebo. D. Change from Baseline in Fatigue Index, time and severity compared to placebo. E. Change from Baseline in Overall performance compared to placebo. F. Change in Serum Lactate levels compared to placebo. Timepoint: A. Baseline, Visit 3 and Visit 5. B. Baseline, Visit 3 and Visit 5. C. Baseline, Visit 3 and Visit 5. D. Baseline, Visit 4 and Visit 6. E. Baseline, Visit 3 and Visit 6. F. Baseline, Visit 3 and Visit 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| A. Change from Baseline in Plasma nitrate and nitrites levels. B. Change from Baseline in Saliva nitrate and nitrites levels. Timepoint: A. Baseline, Visit 3 and Visit 5. B. Baseline, Visit 3, Visit 4, Visit 5, Visit 6. | — |
Countries
India
Contacts
Public ContactYogendra Choudhary
Arjuna Natural Extracts Ltd
Outcome results
None listed