None listed
Conditions
Interventions
Intervention1: LI12542F6 (425 mg), 2 capsules daily in the morning for 8 weeks: Botanical blend supplement for oral administration
Intervention2: LI12542F6 (850 mg), 2 capsules daily in the morning fo
Sponsors
General Nutrition Centers Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject has provided written and dated informed consent to participate in the study. 2.Subject is willing and able to comply with the protocol. 3.Subject is capable of performing recommended physical training & exercise described in the protocol as determined by the investigator. 4.Subject is a male between 19 and 29 years of age with a BMI value equal to or greater than 18.5 kg/m2 to less than 30 kg/m2. 5.Subject is in good health as determined by a health history questionnaire. 6.Subject is a non-smoker and drinking-less than or equal to 2 drinks per day or less than or equal to 14 drinks per week. 7.Subject is willing and able to comply with the protocol including completion of minimum of 70% of workouts. 8.Subject is untrained in resistance/power exercises for at least last 6 months.
Exclusion criteria
Exclusion criteria: 1.Subject is participating in another clinical trial or has received any investigational product within 90 days prior to Visit 1 (Screening). 2.Subject has a history of alcohol and/or other drug abuse in the past year. 3.Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s) that might put the subject at risk and/or confound the results of the study. 4.Subject has a significant history of medical and/or surgical events that may affect the study outcome or place the subject at risk, including bleeding disorder, cardiovascular disease, diabetes mellitus, thyroid disease, gastrointestinal problems, and metabolic, renal, hepatic, neurological or active musculoskeletal disorders. 5.Subject has a history of being diagnosed with phenylketonuria or another disease affecting amino acid metabolism (i.e., maple syrup urine disease, etc.). 6.Subject currently uses nutritional supplements known to improve muscle strength and/or muscle mass (i.e., ribose, protein drinks, amino acids, creatine, HMB, androstenedione, DHEA, shilajit, fenugreek, ashwagandha, etc.), thermogenics within 3 months prior to the start of the study. 7.Subject, currently or during the study period, needs to fast as a personal practice. 8.Subject currently takes any medications that can interfere with muscle mass such as corticosteroid (i.e., Prednisone), testosterone replacement or anabolic drugs (i.e., steroids). 9.Subject has a history of orthopedic injury or surgery within the last year. 10.Subject has a known allergy or sensitivity to herbs/plant products in general and/or allergic to botanical ingredients contained in the study. 11.Subject had an abnormal resting ECG. 12.Subject has an elevated resting heart rate ( >100 bpm) or blood pressure (systolic BP >140 mmHg or diastolic BP >90 mmHg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effects of a botanical blend supplement on muscle strength during resistance training: Changes in bench press and leg extension repetitions at 80% of 1-RM of baseline, compared with placebo.Timepoint: Day 0 (Baseline), Day 14, Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To determine the effects of a botanical blend supplement on muscle endurance during resistance training: Changes in bench press and leg extension repetitions at 80% of 1-RM of baseline, compared with placebo. 2.Safety and efficacy assessment through laboratory analysis of hematological,biochemistry and urine analysis such as Complete Blood Profile, Lipid Profile,Liver Function Test,Kidney Function Test and Serum Testosterone levels.Timepoint: Screening, Day 0 (Baseline; only for Serum Testosterone levels), Day 56 | — |
Countries
India
Contacts
Public ContactDheeraj Kumar Deep
Laila Nutraceuticals
Outcome results
None listed