None listed
Conditions
Interventions
Intervention1: LI80020F4: 800 mg, Two capsules (400mg each) per day after breakfast for 56 Days
Control Intervention1: Placebo: Two capsules per day after breakfast for 56 Days
Sponsors
Aditya Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1.Physically active female subjects aged between 21-45 years with a Body Mass Index (BMI) of approximately 22 to 29 kg/m2. 2.Subjects willing to participate in a week for familiarization session of weight training. 3.Subjects willing to participate in the resistance training as specified by the trainer, during study period and comply with study procedures. 4.Subjects with no history and present complaints of cardiovascular, pulmonary, metabolic, and musculoskeletal diseases. 5.Subjects who are willing to refrain from erogenic supplements use (creatine, HMB, beta-alanine, beetroot, lettuce, radish, celery etc), and amino acid supplements, at least 4 weeks prior to screening and throughout the study period. 6.Subjects who agreed to not take any sudden change in their regular diet throughout the study. 7.Subjects who are willing to participate in the study voluntarily and ready to sign the informed consent form. 8.Subject considered generally healthy as per health history and routine clinical investigations during screening.
Exclusion criteria
Exclusion criteria: 1.subjects having any contraindications to excerise testing as outlined by the American College of Sports Medicine (ACSM). 2.Subjects who have any physical diability which could interfere with their ability to perform the functional performance measures included in this protocol. 3.subjects with history of orthopedic injuries or surgeries in the pervious 6 months. 4.subjects who are having a history or concurrent medical conditions including, but not limited to, cerebrovascular, cardiovascular, gastro-enteric, hormonal, neurological, psychiatric, renal, matabolic, endocrine (such as thyroid disease), genito-urinary, connective tissue diseases, and malignanicies. 5.subjects who are on drugs like anti depressants, hormonal supplements (androgens), steriods, anticholinergic drugs which may impact the study outcomes. 6.subjects with fasting blood glucose levels greater than 125 mg/dl and blood pressure (systolic greater than 140 mmHg and diastolic greater than 90 mmHg). 7.subjects with any anti-oxidants supplemets or Include Subjects with known hypersensitivity/allergy to herbal drugs, nutritional supplements, or even the ingredients of the Investigational product (IP). 8.Subjects with HIV Positive status. 9.Subjects who participated in any interventional study (IP/ Marketed products) within 30 days prior to screening visit. 10.Subjects having history of psychiatric disorder which may impair the ability of subjects to provide written informed consent. 11.Subjects who are pregnant, lactating or planning to become pregnant during the study. 12.Subjects with any clinically significant findings that, in the opinion of the investigator, would adversely affect the subject s ability to complete the study or its measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: 1 RM-bench press and leg extensionTimepoint: Days 1,14,28, and Day 56. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in : treadmil excerise.Timepoint: Days 1,14,28, and Day 56.;Change from baseline to the end of the study period in : Relative peak powder output (watts/kg) in counter movement jump test (CMJ).Timepoint: Days 1,14,28, and Day 56.;Change from baseline to the end of the study period in: Jump height by counter movement jump test (CMJ).Timepoint: Days 1,14,28, and Day 56.;Change from baseline to the end of the study period in : Hand grip strength (HGS) measured using a hand held dyanamometer.Timepoint: Days 1,14,28, and Day 56.;Change from baseline to the end of the study period in : Distance in medicine ball throw (MBT).Timepoint: Days 1,14,28, and Day 56.;Change from baseline to the end of the study period in : Multi-dimensional fatigue inventory (MFI).Timepoint: Days 1,14,28, and Day 56.;Change from baseline to the end of the study period in : Average energy level and their overall well-being on a 10 cm VAS scale.Timepoint: Days 1,14,28, and Day 56.;Change from baseline to the end of the study period in : The single-item assessment of quality of life.Timepoint: Days 1,14,28, and Day 56. | — |
Countries
India
Contacts
Public ContactDr S Ramya Krishna
ADITYA RESEARCH CENTER
Outcome results
None listed