FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/063205 [Registered on: 27/02/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Creatine in improving muscle health and wellbeing 
Scientific Title of Study   A Randomized, Controlled Clinical Study on Creatine Monohydrate Supplement: Pharmacokinetics, Bioavailability, Safety and Efficacy in Enhancing Strength, Power, Muscle volumization,Energy, and Lean Body Mass in Active Males. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/23-24/036 Version: 1.00; dated 08 January 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre 
Address  Lokmanya Medical Research Centre Fourth-floor OPD 401-314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  501-514, Crossroads, Wakad

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  clinical@mprex.in  
 
Details of Contact Person
Public Query  
Name  Mr Jeetesh Gidwani 
Designation  Head of Food and Nutraceutical Division 
Affiliation  Lasons India Pvt. Ltd. 
Address  Unit # 504, Hallmark Business Plaza,Sant Dyaneshwar Marg, Opposite Guru Nanak hospital, Bandra East

Mumbai
MAHARASHTRA
400051
India 
Phone  9999681990  
Fax  -  
Email  bdm@lasons.com  
 
Source of Monetary or Material Support  
Lasons India Pvt. Ltd.  
 
Primary Sponsor  
Name  Lasons India Pvt. Ltd. 
Address  Unit # 504, Hallmark Business Plaza, Sant Dyaneshwar Marg, Opposite Guru Nanak hospital,Bandra East, Mumbai 400051 Maharashtra 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Fourth-floor OPD 401-314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male Participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  (Group A): Creatine Monohydrate (KleanCREATINEâ„¢)  3g of the KleanCREATINEâ„¢ (only 1 serving) in 240 ml of water or fruit juice. Mix well for 30-45 seconds. 
Comparator Agent  (Group B): Creatine Monohydrate (Marketed preparation)  3g of the marketed preparation (only 1 serving) in 240 ml of water or fruit juice. Mix well for 30-45 seconds. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  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.  
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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.
 		 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 Outcome  
Outcome  TimePoints 
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. 		 At day 1, weeks 4, and 8. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   03/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Despite the popularity and widespread use of creatine supplements, a comprehensive understanding of the mechanisms governing the absorption, distribution, metabolism, and excretion of creatine is crucial. This is especially important to optimize supplementation strategies, specifically tailored for active males. Bioavailability studies play a key role in demonstrating that recommended doses of creatine monohydrate effectively increase muscle creatine content, thereby contributing to its potential efficacy in enhancing physical performance. Ensuring the safety profile of prolonged creatine supplementation, especially in active males undergoing resistance training, is paramount. Therefore, a comprehensive investigation will provide evidence-based recommendations for both athletes and healthcare professionals. Our study seeks to rigorously evaluate the efficacy of creatine monohydrate in enhancing strength, power, muscle volumization, energy levels, and lean body mass in active males through controlled and randomized clinical trials. This approach substantiates the potential ergogenic benefits of creatine monohydrate supplementation while ensuring the absence of untoward side effects. Moreover, the investigational product is designed for convenient consumption, with greater solubility (being 100% water-soluble) and no residual content, facilitating faster absorption into the blood and potentially promoting more efficient transport of creatine to the muscles. Creatine monohydrate, considered the gold standard for comparing other purported sources of creatine, boasts well-established physiochemical properties, high bioavailability, and extensive evidence supporting its efficacy and safety. Our study aims to contribute to the existing body of evidence supporting the bioavailability, efficacy, and safety of creatine monohydrate, aligning with professional guidelines and regulatory approvals in major global markets. This enables consumers to make informed decisions about the supplements they choose to consume. Thus, the proposed study on creatine monohydrate supplementation in active males aims to provide comprehensive insights into its pharmacokinetics, bioavailability, safety profile, efficacy in enhancing physical performance, and comparison with other forms of creatine. By addressing these critical aspects, the study endeavours to contribute to evidence-based recommendations for the use of creatine monohydrate as a dietary supplement, particularly in the active males. 
Close