None listed
Conditions
Interventions
Intervention1: (Group A): Creatine
Monohydrate
(KleanCREATINE™): 3g of the KleanCREATINE™
(only 1 serving) in 240 ml of
water or fruit juice. Mix well for
30-45 seconds.
Control Intervention1: (Group
Sponsors
Lasons India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male participant of age 18-40 years having BMI less than 30 kg/m2. 2. Participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations. 3.Engaged in regular resistance training for at least 1 year and agreeing to continue throughout the study. 4. No previous history of creatine supplementation in the last one month, However, participants from phase I are eligible to continue their participation in phase II after 7 days of washout period. 5. Availability of volunteers for the entire study duration. 6. Ability to fast for at least 14.00 hours and consume standard meals 7. Willingness to provide consent and agree to come for follow up associated with the study.
Exclusion criteria
Exclusion criteria: 1. Any known contraindications to creatine supplementation; 2. Any individual who is currently being treated or is diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic obesity, immune, autoimmune, psychiatric, hematological, neurological, or endocrinological disorder or disease; 3. Current use of performance-enhancing drugs or supplements; 4. History of renal and/or liver dysfunction or disease; 5. Taking medications that affect muscle biology; 6. Planning to travel for more than 1 week during the study, where there will be NO access to a fitness facility; 7. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: 1. Pharmacokinetics parameters like F, Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, and Kel will be calculated from the concentration Vs. time data. Phase II: 1. Changes in muscle strength using a standard plate-loaded leg press and chest press machine, Rep max for leg press and chest press at day 1, weeks 4, and 8. 2. Changes in hypertrophy measurements of each muscle site (cm) of the biceps, triceps, quads, and hamstrings at day 1, weeks 4, and 8. Timepoint: 1) Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before IP administration] & post-dose at at 0.5 hour (h), 1h, 2 h, 3 h, 4 h, 5 h, and 6 h. 2)Phase II At day 1, weeks 4, and 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: 1. Changes in muscle endurance using a standard plate-loaded leg press and chest press machine by measuring Reps to fatigue at 50% 1-Rep Max at day 1, weeks 4, and 8. 2. Changes in the Body Composition using a BIA at day 1 and end of the study visit (week 8). 3. Assessment of changes in the anthropometric parameters such as body weight, BMI at day 1 and week 8. 4. Changes in the rating of perceived exertion at day 1, weeks 4, and 8. Modified to encompass the entire training day. 1-10 scale as to how hard that workout was. The higher the scale score, the harder the workout felt to the participant.Timepoint: At day 1, weeks 4, and 8. | — |
Countries
India
Contacts
Public ContactMr Jeetesh Gidwani
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed