A clinical trial to evaluate Efficacy and Safety of LI80020F4 in improvement of Muscular Energy, Endurance, and Muscle Strength

Completed

Conditions: Muscle Energy , Endurance and Muscle strength

Registration Number: CTRI/2015/01/005374

Lead Sponsor: Laila Nutraceuticals

Brief Summary: The purpose of this study is to assess improvement of Muscular Energy, Endurance, and Muscle Strength as measured by 1 repetition maximum (1-RM) of LI80020F4 versus placebo in resistance trained Healthy Male Subjects. Enrolled subjects will receive either LI80020F4 or a placebo for 6 weeks.

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40 males of age 18 - 40 years, resistance trained healthy subjects will be enrolled into the study through Screening Criteria for 49 days. Assessment of blood and urine will be carried out at screening and final visit. Assessment of serum biomarkers shall be carried out during the randomization and final study visit. The study is to be carried out at one center, to recruit 40 subjects to assess the study specific objective to evaluate efficacy of LI80020F4 in improving Muscular energy, Endurance and Muscle Strength.

To evaluate the safety and tolerability of the LI80020F4 by monitoring the vital signs and possibility of adverse events at each follow-up visits

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

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 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.

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 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 â‰¥ 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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscular Endurance	Day 7, 21,35 and 49
Muscle strength	Day 7, 21,35 and 49
(It will be measured by 1-RM in bench Press and leg Press) and	Day 7, 21,35 and 49
Change from the baseline to the end of the supplement period in	Day 7, 21,35 and 49
(It will be measured by total number of repetitions and weight lifted via leg extensions)	Day 7, 21,35 and 49

Secondary Outcome Measures

Name	Time	Method
Change from the baseline to the end of the supplement period in :	â€¢Time to Exhaust in Treadmill (Day-7, Day 21, Day 35, and Day-49).

Trial Locations

Locations (1): Suraksha Health Village
🇮🇳
Krishna, ANDHRA PRADESH, India
Suraksha Health Village
🇮🇳Krishna, ANDHRA PRADESH, India
Dr K Manikyeswara Rao
Principal investigator
9866377188
surakshahealthvillage@gmail.com