None listed
Conditions
Interventions
Intervention1: Sports Nutrition Capsules: Once a day, 500 mg, 1 capsule per day for 1 month total duration
Control Intervention1: Placebo Capsules: Once a day for 1 month total duration
Sponsors
Aurea Biolabs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male healthy adult subjects ranging in age from 18 to 55 years (both inclusive) normotensive, physically active but not exercise trained. 2 Willingness to follow the protocol requirements as evidenced by written, informed consent. 3 Agree not to use any medication including vitamins and minerals, during or before the course of this study. 4 Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range. 5 Non smokers and non-alcoholics. 6 Willing to come for all follow-up visits
Exclusion criteria
Exclusion criteria: Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate, temperature) hematology, serum chemistry. History of hypersensitivity reactions. Smokers and alcoholics History of migraine, asthma Participation in a clinical study during the preceding 90 days. Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (ECG) ( > 1mm ST segment depression), regional wall motion abnormalities, left ventricular systolic dysfunction or significant valvular disease. Blood or blood products donated in past 30 days prior to study supplement administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lactate levels â?? pre & post exercise Heart rate Time to exhaustion 12 lead -Electrocardiogram (ECG) for arrhythmia patterns, ST and RR segments. Exercise test on treadmill (Bruce treadmill test) Plasma and saliva NO 3 and NO 2 levels at pre and post exercise on Day 0 and Day 22Timepoint: Lactate levels â?? pre & post exercise Heart rate Time to exhaustion 12 lead -Electrocardiogram (ECG) for arrhythmia patterns, ST and RR segments. Exercise test on treadmill (Bruce treadmill test) Plasma and saliva NO 3 and NO 2 levels at pre and post exercise on Day 0 and Day 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by Adverse Events ï?· Pharmacokinetic profiles of active Vs placeboTimepoint: Day 0 and Day 22 | — |
Countries
India
Contacts
Public ContactJeevan
Agile Pharma Services
Outcome results
None listed