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CTRI Number  CTRI/2024/09/074472 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to Evaluate The Efficacy of MA2/24 in Comparison with Caffeine on Mood, Energy, Focus,Attention and Fatigue in Healthy Working-Class Subjects. 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, 4-Arm, Parallel Group, Active-Controlled Study to Evaluate The Efficacy of MA2/24 in Comparison with Caffeine on Mood, Energy, Focus,Attention and Fatigue in Healthy Working-Class Subjects. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-AK-125, Version 1.0 dated 15-Jul-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohan ME 
Designation  Dean/Principal, Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No.03, Ground Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
56006
India 
Phone  8792516793  
Fax    
Email  drmohanbgsresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin VThomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin VThomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road


KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Akay Natural Ingredients Private Limited, Malaidamthuruthu P. O Ernakulam, Cochin 683561 Kerala, India  
 
Primary Sponsor  
Name  Akay Natural Ingredients Private Limited, 
Address  Malaidamthuruthu P. O Ernakulam, Cochin 683561 Kerala, India  
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients]] 
 
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 Mohan ME  BGS Global Institute of Medical Sciences  Research Deaprtment, 5th Floor, No. 67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 8792516793

drmohanbgsresearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Commitee, BGS Global Institute of Medical Sciences  Approved 
Institutional Ethics Committee,BGS Global Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  requiring improvement in focus , attention and energy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caffeine   One sachet in 200ml water once in a day for 28 days 
Intervention  MA2/24 + Caffeine   One sachet in 200ml water once in a day for 28 days 
Intervention  MA2/24- sachet   One sachet in 200ml water once in a day for 28 days 
Comparator Agent  Placebo  One sachet in 200ml water once in a day for 28 days 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male and female subjects who are working-class professionals
2.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive)
3.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
4.Subjects willing to refrain from taking any medications or preparations to improve fatigue (herbal, dietary supplements, homeopathic preparations, etc.) during the study.
5.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days.
6.Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.
7.Subjects willing to refrain from vigorous physical activity 12 hours prior to visit days.
8.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
9.Having basic computer literacy and exposure to computerized tests.
10.Must be willing and able to give informed consent and comply with the study procedures.
11.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study
 
 
ExclusionCriteria 
Details  1.Consumption of any cognition, energy and mood improving medicines, alcohol, tobacco, or any other Central Nervous System (CNS) acting medicines.
2.Having hypersensitivity or history of allergy to the study product.
3.Subjects with moderate to severe fatigue or having chronic fatigue syndrome.
4.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection
5.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
6.Subjects with a psychiatric diagnosis other than anxiety or depression.
7.Subjects with sleep disturbances and or are taking sleep aid medication.
8.Subjects with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening.
9.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications.
10.Subjects with a history of drug and or alcohol abuse at the time of enrolment.
11.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
12.Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit.
13.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
14.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of BF-24 arms compared to placebo in Cognitive Performance  Day 1, Day 3, Day 7, Day 14, Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of BF-24 arms on Blood Biomarkers  Day 1, Day 3, Day 7, Day 14, Day 28 
Overall Safety  Day 1, Day 3, Day 7, Day 14, Day 28 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   30/09/2024 
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="3"
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   This is a randomized, double-blind, active-controlled, 4-treatment arms, parallel group, clinical interventional study. Adult healthy males and/or females, working professionals, aged between 35 and 65 years old and meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. After the informed consent process, demographic details such as date of birth, sex, ethnicity and race will be obtained. Medical history including hypertension, diabetes mellitus, chronic liver, gastrointestinal and renal disorders, surgeries, any other clinically significant medical and medication history including dementia will be obtained. Subjects found eligible for study participation will be randomized into one of the 4 treatment arms (1:1:1:1) as per randomization schedule for a treatment period of 28 days. The study will be conducted over  6 visits on baseline, day  1, 3, 7, 14 and 28 and tests for cognitive assessments will be performed. 
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