None listed
Conditions
Interventions
Intervention1: CL19183: 450 mg, One capsule in the morning before breakfast (60 minutes prior to assessments) for 4 days (2 days in each phase)
Control Intervention1: Placebo: One capsule in the morni
Sponsors
CLS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men and women aged between 20 and 35 years with a Body Mass Index (BMI) of approximately 18.5 to 29.9 kg/m2. 2.Recreationally active subjects who participate in sports / athletics 2-3 times per week (includes long distance running, baseball, cycling, soccer, triathlon and skiing). 3.Subjects who consent to refrain from taking pre-workout supplement, for at least 2 weeks prior and during the study. 4.Subjects willing to avoid beverages, vitamins (Such as Folate, B12, and B6 containing multivitamins), ergogenic supplements (caffeine from any source including coffee, tea, cola, chocolate, drugs, dietary and/ or herbal supplements, etc..) 12 hr. before the evaluation days and during the study period. 5.Subject willing to avoid beetroot, berry and grape based products such as whole fruit, fruit juice, etc. in the diet for 2 weeks prior to the study and during the course of the study. 6.No history of chronic knee pain or knee injury in prior year. 7.Subject agrees to maintain existing dietary patterns throughout the study period. 8.ECG without clinically significant abnormalities. 9.Results of screening are within normal range or considered not clinically significant by the Principal Investigator. 10.Willing and able to sign informed consent and complete all tests and procedures as listed in the protocol. 11.Female subjects are willing to take a pregnancy test and test negative. 12.Female subjects aware about the stage of their menstrual cycle and willing to share the information. 13.Female subjects use an acceptable form of contraception for 2 weeks before and during the study.
Exclusion criteria
Exclusion criteria: 1.Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 6 months or tested positive during the study will be excluded. 2.Subject participating in another clinical trial or has received an investigational product within thirty days prior to enrolment. 3.High alcohol intake (greater than 2 standard drinks per day), smokers (greater than 5 cigarettes per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.). 4.Individuals consumed analgesic or NSAIDs within one week prior to screening. 5.Significant or untreated medical and/or psychiatric disorders including but not limited to recent myocardial ischemia or infarction, unstable angina, renal failure and serious renal diseases, chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS, malignancy and including epilepsy, recent cerebrovascular disease and recent traumatic brain injury. 6.Use of any dietary supplements that may impact muscle recovery or performance (i.e. supplemental protein, amino acids, creatine, beta-alanine, L-citrulline, caffeine, metabolites/ derivatives of caffeine, omega 3 fatty acids, BCAA’s, glutamine, etc.) within the month prior to randomization. 7.Usage of medications, anabolic agents including steroids, stimulants, or any medication which affects the study outcome. 8.Subjects previously diagnosed to physical or motor conditions that affect physical stability and precision during physical activities. 9.Any clinically significant gastrointestinal or haematological illness or unstable medical condition which could interfere with investigational supplement safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol. 10.Subjects have known obstructive pulmonary disease or asthma. 11.Subjects with Systolic greater than 140 and Diastolic greater than 90 mmHg blood pressure and Fasting blood glucose (FBG) greater than 120 mg/dl. 12.Subject have a recent (Less than or equal to 6 months) major surgery or surgery scheduled in the next 4 to 5 weeks. 13.Subject has lost ten or more pounds during the previous three months and has maintained the weight loss. 14.Allergy or sensitivity to study supplement ingredients. 15.Individuals who are cognitively impaired. 16.Subjects, who are pregnant, breast feeding or planning to be pregnant during study period. 17.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 |
|---|---|
| Change in the following outcomes from baseline to end of the study period in: Time to Exhaustion (TTE) using Ergometer (VO2 max of 85%)Timepoint: Baseline and Day 2 - after 60 min post dose (Phase-I & Phase-II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study period in: Rate of perceived exertion (RPE)Timepoint: Baseline and Day 2 - after 60 min post dose (Phase-I & Phase-II);Change from baseline to end of the study period in: Flow mediated dilation (FMD)Timepoint: Baseline – Pre exercise and 20 mins post exercise, Day 1 - after 60 min post dose and Day 2 - 20 mins post exercise (Phase-I & Phase-II);Change from baseline to end of the study period in: Salivary nitric oxide (NO)Timepoint: Baseline – Pre exercise and 20 mins post exercise, Day 1 - after 60 min post dose and Day 2 - 20 mins post exercise (Phase-I & Phase-II) | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt Ltd
Outcome results
None listed