A clinical trial to evaluate Efficacy and Safety of LI80020F4 in improvement of Muscular Energy, Endurance, and Muscle Strength
- Registration Number
- CTRI/2015/01/005374
- Lead Sponsor
- aila Nutraceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Male subjects between 18-40 years of age
Ability to understand the risks/benefits of the protocol
Subjects familiar with weight training and have at least 6 months experience training, 4 times per week for at least 3 to 4hours. (Recreational athletes)
Agree to do physical activities as stated in the protocol in presence of physical trainer
Willingness to participate in an exercise program (4 days a week, during the course of the study)
Subjects should be available for duration of study period (7weeks)
Subject agrees not to start any new supplement which would affect body composition during the course of the study
Subjects agree to maintain the activity dairy
Willing to give written informed consent and willing to comply with trial protocol
No contraindications to exercise as outlined by the American College of Sports Medicine (ACSM).
Use of nutritional supplements known to improve energy and muscle strength and/or muscle mass (e.g., Creatine, HMB, androstenedione, DHEA, etc.) within seven weeks prior to the start of the study.
All medications that can interfere with muscle mass such as corticosteroids (e.g. Prednisone), testosterone replacement or anabolic drugs.
Subjects who are under herbal supplements within seven (7) days prior to screening.
Subjects using any other therapies that would affect body composition other than those revealed during recruitment process.
Subjects having history of asthma.
Subjects having history of cardiovascular diseases.
Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose >= 140-199 mg/dl.
Subjects having thyroid disease.
Subjects having abnormal liver or kidney function tests (ALT or AST 2 times the upper limit of normal; elevated Creatinine, males 125 µmol/L,).
Subjects having abnormal findings on complete blood count
Subjects with HIV Positive.
Subjects having history of high alcohol intake (2 standard drinks per day).
Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures.
Subjects participated in any clinical study within thirty (30) days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from the baseline to the end of the supplement period in <br/ ><br> <br/ ><br> <br/ ><br>Muscle strength <br/ ><br>(It will be measured by 1-RM in bench Press and leg Press) and <br/ ><br> <br/ ><br>Muscular Endurance <br/ ><br>(It will be measured by total number of repetitions and weight lifted via leg extensions) <br/ ><br>Timepoint: Day 7, 21,35 and 49 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change from the baseline to the end of the supplement period in : <br/ ><br>â?¢Time to Exhaust in Treadmill (Day-7, Day 21, Day 35, and Day-49). <br/ ><br>â?¢Measurement in Arm circumference (muscle size), Body-composition analysis by DEXA (Day-7 and Day-49), <br/ ><br>â?¢Change in Serum biomarker like IGF-1, IGFBP-3, Free Testosterone, Insulin and Lactate. Lactate will be assessed before the starting of treadmill exercise (pre-exercise) and after achieving the exhaust time (post exercise) at baseline and Day-49. <br/ ><br>Timepoint: Day 7 and 49 <br/ ><br> <br/ ><br>