| CTRI Number |
CTRI/2025/07/090557 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study of beta alanine complex plus in comparison with beta alanine complex and conventional beta alanine in healthy human adults in fasting conditions. |
|
Scientific Title of Study
|
A double-blind, randomized, single dose, three-treatment, three-way crossover oral bioavailability study of beta alanine complex Plus in comparison with beta alanine complex and conventional beta alanine in healthy human adults under fasting conditions. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| VCR-CSP-25/018 Version No: 1.0 Date: 06 May 2025 |
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 and Diagnostics at 38/1, Church Road, Marappa Garden, J C Nagar
Bangalore
KARNATAKA
560006
India |
| Phone |
09845270377 |
| Fax |
- |
| Email |
gowdaambanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambanna Gowda |
| Designation |
Consultant Physician |
| Affiliation |
Unitree Health Care Diagnostics |
| Address |
Unitree Health Care and Diagnostics at 38/1, Church Road, Marappa Garden, J C Nagar
KARNATAKA
560006
India |
| Phone |
09845270377 |
| Fax |
- |
| Email |
gowdaambanna@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
KARNATAKA
560079
India |
| Phone |
09980107723 |
| Fax |
- |
| Email |
vivatiqcr@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOLECULES BIOLABS PRIVATE LIMITED
Building No.III/634, First Floor, Commercial Building Kinfra Small Industrial Park Koratty,
Kerala 680309. 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 |
Unitree Health Care and Diagnostics at 38/1, Church Road, Marappa Garden, J C Nagar
Bangalore
KARNATAKA |
09845270377
-
gowdaambanna@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ergogenic aid. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Beta alanine complex Plus liquid containing 400 mg of beta alanine |
In morning, single dose of 40ml to be taken with water in fasting condition. |
| Comparator Agent |
Reference product (R1) - 400 mg beta-alanine complex liquid |
In morning, single dose of 40ml to be taken with water in fasting condition. |
| Comparator Agent |
Reference product (R2) - 400 mg Conventional beta-alanine liquid |
In morning, single dose of 40ml to be taken with water in fasting condition |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, adult, male and female human subjects of age between 50-65 years with a body mass index (BMI) range between 18.50 kg per m2 to 24.99 kg per m2 .
2. Subject agrees avoid beta-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.
5. Subjects whose screening laboratory values are within normal limits or considered by the physician or principal investigator to be of no clinical significance.
6. Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
7. Generally healthy as documented by clinical laboratory assessments.
8. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
9. Willing to consume ova-lacto vegetarian diet.
10. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
11. Female subjects within normal limits or clinically non-significant laboratory evaluation results for FSH and LH.
12. Generally healthy as documented by gynecological examination and breast examination (for female subjects during check-in only).
|
|
| ExclusionCriteria |
| Details |
Evidence or history of clinically significant medical conditions.
2. Evidence of allergy or known hypersensitivity to beta alanine or other related drugs or other related drugs.
3. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
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 Beta alanine metabolism.
7. Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than100 per min ventricular rate.
8. Gastrointestinal bleeding in past three months.
9. Uncontrolled diabetes mellitus.
10. Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
11. Psychopathic disorder, lack of cooperation.
12. Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months)
13. Taking more than 100 mg beta-alanine daily within 2 weeks to screening.
14. Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study
15. Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the oral bioavailability of investigational product (beta-alanine complex Plus liquid (400 mg)), reference product I Beta-alanine complex liquid (400 mg)) and reference product II (Conventional beta-alanine liquid (400 mg)) in healthy, adult, Human participants under fasting conditions.
|
baseline and End of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the adverse events & to ensure the safety of the subjects.
|
Baseline & end of study. |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The benefits of beta-alanine supplementation on functional performance in older adults have been reported in several investigations. These human studies have demonstrated that supplementing with beta-alanine can delay fatigue, increase strength, and improve functional performance (e.g., sit to stand) . Limited research has indicated that beta-alanine supplementation in older adults is also associated with improved executive function. Although increasing tissue carnosine levels have been reported to improve health in older adults, there is only limited scientific evidence supporting the efficacy of beta-alanine as a therapeutic intervention to improve cognitive function and memory in this population. The increase in carnosine in the muscle 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. |