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CTRI Number  CTRI/2024/03/063457 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A single dose three-way crossover oral bioavailability study of β-alanine capsules in comparison with conventional β-alanine in healthy human volunteers in fasting conditions 
Scientific Title of Study   A double blind, randomized, single dose, three treatment, three way crossover, oral bioavailability study of investigational product containing β- analine in healthy, adult, human participants under fasting conditions. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
VCR-CSP-24/004 ver1.0 dated28Jan2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics at 38/1 Church Road Marappa Garden J C Nagar Bengaluru

Bangalore
KARNATAKA
560006
India 
Phone  9845270377  
Fax  -  
Email  unitreeclinicalresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics at 38/1 Church Road Marappa Garden J C Nagar Bengaluru


KARNATAKA
560006
India 
Phone  9845270377  
Fax  -  
Email  unitreeclinicalresearch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shalini Dayananda 
Designation  Project Manager 
Affiliation  Vivatiq Clinical Research 
Address  358/274, Srigandha Nagar Main Road, Hegganahalli, Vishwaneedam Post, near Peenya Industrial Area 2nd stage Bangalore

Bangalore
KARNATAKA
560079
India 
Phone  9980107723  
Fax  -  
Email  vivatiqcr@gmail.com  
 
Source of Monetary or Material Support  
Unitree Health Care Diagnostics at 38/1, Church Road, Marappa Garden, J C Nagar, Bengaluru 560006, Karnataka, India 
 
Primary Sponsor  
Name  Natural Alternatives International  
Address  1535 Faraday Avenue, Carlsbad, CA 92008-7319 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Academy of Material Research  Mahatma Gandhi University Innovation Foundation Building No. 572 Priyadarshini Hills Athirampuzha Kottayam Kerala India  
MOLECULES BIOLABS PRIVATE LIMITED   Building No.III/634 First Floor Commercial Building Kinfra Small Industrial Park Koratty Kerala India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ambanna Gowda  Unitree Health Care Diagnostics   38/1 Church Road Marappa Garden J C Nagar
Bangalore
KARNATAKA 		 9845270377
-
unitreeclinicalresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ergogenic aid 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  β-alanine complex (400 mg)  one capsule to be taken with water per day (daily for 30 days) 
Comparator Agent  Reference Product I - Conventional β-alanine (400 mg)   one capsule to be taken with water per day (daily for 30 days) 
Comparator Agent  Reference Product II: Conventional β-alanine (1200 mg)   one capsule to be taken with water per day. (on Day1) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Normal healthy adult male and female human subjects of age between 18-65 years with a body mass index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2
2.Subject agrees avoid ß-alanine containing medications and dietary supplements from screening until last visit.
3.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
4.Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check in.
 
 
ExclusionCriteria 
Details  1.Evidence of allergy or known hypersensitivity to ß-alanine or other related drugs or other related drugs.
2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
3.Any major illness in the last three months or any significant ongoing chronic medical illness.
4.Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
5.History of alcohol addiction or abuse.
6.Malabsorption syndrome that affects β-alanine metabolism.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the oral bioavailability of investigational product (β-alanine complex (400 mg)), reference product I (Conventional β-alanine (400 mg)) and reference product II (Conventional β-alanine (1200 mg)) in healthy, adult, Human participants under fasting conditions  day 1 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of the subjects.  da1, day30 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/03/2024 
Date of Study Completion (India) 13/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   β-Alanine (or beta-alanine) [3-aminopropanoic acid] is a naturally occurring beta amino acid, which is an amino acid in which the amino group is attached to the β-carbon. BA, a precursor of carnosine, has been shown to increase intracellular levels of carnosine and reduce acidosis during high-intensity exercise. This indicates that carnosine may act as a physiologically meaningful physiochemical buffer. In normal conditions, rate of BA production is relatively low and serum BA concentration is undetectable. If there is an increase in BA to a detectable level in the bloodstream, there may also be a subsequent increase in carnosine in the muscle. This increase has been considered as enhancing blood buffering capacity and decreasing neuromuscular fatigue. Thus, the rationale of supplementing with BA as an ergogenic aid has often been described to increase athletic performance. 
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