A clinical Trial to Evaluate the Efficacy and Safety of LI12542F6 in improvement of Muscular Energy, Endurance, and Muscle Strength

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

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 with 4 times per week for at least 3 to 4 hours (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 entire duration of study period (8 weeks).

Ready to refrain from exercise for 2 days before the baseline evaluation.

Subject agrees not to consume any supplement which would affect body composition during the entire course of the study.

Subjects agree to maintain the activity diary.

Willing to give written informed consent and willing to comply with trial protocol.

Exclusion Criteria

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 cardiovascular or respiratory disorders.

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 parameters (ALT or AST 2 times the upper limit of normal; elevated Creatinine, males 125 Âµmol/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 visit.

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>Muscle strength <br/ ><br>(It will be measured by 1-RM in bench Press and <br/ ><br>leg Press) and Dynamometer test.Timepoint: Day 7,21,35 and 63

Secondary Outcome Measures

Name	Time	Method
Change from the baseline to the end of the supplement period in: <br/ ><br>Muscular Endurance (It will be measured by total number of repetitions and weight lifted via Cable Pull Down) <br/ ><br>Time to Exhaust in Treadmill <br/ ><br>Measurement in Arm circumference (muscle size) <br/ ><br> <br/ ><br>Timepoint: Day 7,21,35 and 63;Change in body composition analysis by DEXA. <br/ ><br>Serum biomarker- Lactate.(It will be assessed immediately after achieving the treadmill exhaust time and after 30 min post exercise. <br/ ><br>Other serum biomarkers like Free Testosterone, Dihydrotestosterone, and Insulin on Day 7 and 63Timepoint: Day 7 and 63