None listed
Conditions
Interventions
Intervention1: LI51202F1 60 mg: 1 sachet mix with 200 ml of water to be consume within 10 min after breakfast for 10 days
Control Intervention1: Placebo: 1 sachet mix with 200 ml of water to be consum
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: Ambulatory, male subjects aged between 25 and 40 years with a Body Mass Index (BMI) of approximately 20 to 29.9 kg per m2. Recreationally active subjects with average levels of any of the following exercises over prior 6 months within the limits Resistance exercise between greater than or equal to 15 and less than 30 min per week. and or Low to moderate intensity aerobic exercise between greater than or equal to 30 and less than 60 min per week. and or Recreational sport participation greater than or equal to 1 and less than 3hrs per week. No history of chronic knee pain. No knee injury in prior year. Subject agrees to maintain existing dietary patterns throughout the study period. Subject agrees to abstain from strenuous exercise (except the proposed exercise protocol) throughout study period. Subject agrees to abstain from participation in recovery strategies such as massage, stretching, foam rollers, topical pain relievers, ice or cryotherapy. Subject agrees to abstain from use of analgesics, NSAIDs and dietary supplements for the duration of the study. Subject should read, write and understand English language. Subject is willing and able to comply with the study protocol. Has given voluntary, written, informed consent to participate in the study. Subject agrees to abstain from alcohol use during the study period. Subject agrees to abstain from coffee, caffeinated beverages and cigarettes on all testing days.
Exclusion criteria
Exclusion criteria: Participation in a formal exercise program or resistance training in the 6 months preceding screening (see recreationally active limits defined in inclusion criteria, subjects exceeding any of the defined upper limits will be ineligible). Participation in any eccentric exercise (that is downhill running, eccentric weight training, etc) or other activity that resulted in muscle soreness in past 6 months. Individuals consumed analgesic or NSAIDs within one week prior to screening. Unstable medical conditions. Significant or untreated medical and or psychiatric disorders including but not limited to severe uncontrolled diabetes, recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, marginal glycemic control in diabetes mellitus, renal failure and serious renal diseases, chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS, malignancy and neurological disorders including epilepsy, recent cerebrovascular disease and recent traumatic brain injury. Use of any dietary supplements that may impact muscle recovery or performance (that is supplemental protein, amino acids, BCAAs, glutamine, etc.) within the month prior to randomization. Alcohol consumption (greater than 2 standard alcoholic drinks per day) or drug abuse or dependence within the past 6 months. Smokers (more than 3 cigarettes per day). Clinically significant abnormal laboratory results at screening. Participation in a clinical study within 30 days prior to randomization. Allergy or sensitivity to study supplement ingredients. Individuals who are cognitively impaired and or who are unable to give informed consent. Any other condition which in the Investigators opinion may adversely affect the subjects ability to complete the study or its measures or which may pose significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between group differences in: Muscle recovery as assessed by muscle soreness during squat (100 mm VAS) Timepoint: Day1,8,9 and 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee soreness while descending stairs(100 mm VAS)Timepoint: Day1,8,9 and 10;Knee soreness while squatting (100 mm VAS)Timepoint: Day1,8,9 and 10;Markers of inflammation, muscle damage & connective tissue damage (IL-6, hsCRP, CK, uCTX-II and COMP)Timepoint: Day 1,7(pre and post exercise), 8,9 and 10 COMP will be done only at Day 1 and Day 7(pre and post exercise);Muscle soreness while descending stairs(100 mm VAS)Timepoint: Day1,8,9 and 10;Overall stiffness (100 mm VAS)Timepoint: Day1,8,9 and 10;Post-exercise between group differences in: Recovery of strength (1RM leg extension)Timepoint: Day1,8,9 and 10;Rating of Perceived Exertion (RPE) during 1RM leg extension assessmentTimepoint: Day1,8,9 and 10;Recovery of range of motion (both knees)Timepoint: Day1,8,9 and 10 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar
Laila Nutraceuticals
Outcome results
None listed