| CTRI Number |
CTRI/2025/10/096030 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Other (Specify) [Food probiotic beverage ] |
| Study Design |
Other |
|
Public Title of Study
|
Probiotic Beverage Trial for Healthy Aging in Indian Adults |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled trial evaluating a probiotic beverage for aging-related biomarkers in Indian adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaila Nova Henna Jemimah |
| Designation |
Ms. |
| Affiliation |
CSIR- CFTRI |
| Address |
PhD student, Lab 2, Animal House Facility, Department of Biochemistry, CSIR- Central Food Technological Research Institute, Mysuru, Karnataka, India
Mysore
KARNATAKA
570020
India |
| Phone |
9542079547 |
| Fax |
|
| Email |
njems768@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Muthukumar S. P |
| Designation |
Dr. |
| Affiliation |
CSIR- CFTRI |
| Address |
Lab 2, Animal House Facility, Department of Biochemistry, CSIR- Central Food Technological Rsearch Institute, Mysuru, Karnataka, India
Mysore
KARNATAKA
570020
India |
| Phone |
9542079547 |
| Fax |
|
| Email |
muthukumar@cftri.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Kaila Nova Henna Jemimah |
| Designation |
Ms. |
| Affiliation |
CSIR- CFTRI |
| Address |
PhD student, Lab 2, Animal House Facility, Department of Biochemistry, CSIR- Central Food Technological Rsearch Institute, Mysuru, Karnataka, India
Mysore
KARNATAKA
570020
India |
| Phone |
9542079547 |
| Fax |
|
| Email |
njems768@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CSIR |
| Address |
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prathima C |
JSS Medical College |
JSS Medical College Bannimantap A Layout Bannimantap Mysuru Karnataka 570015
Mysore
KARNATAKA |
9886100388
prathimac@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Aging |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metformin tablets (positive control). |
Metformin tablets (positive control). |
| Intervention |
Probiotic millet beverage |
The study will observe and compare influence of the beverage on aging biomarkers. The intervention groups include:
(1) Non-probiotic beverage (NPB, placebo control),
(2) Lactobacillus plantarum strain 1 beverage (LPDB),
(3) Lactobacillus plantarum strain 2 beverage (LPMB)
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria include healthy adults aged 40-65 years with BMI 18.5-29.9 kg/m², no chronic diseases, and ability to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria encompass diagnosed psychiatric/neurodegenerative disorders, recent antibiotic or probiotic use (within 30 days), pregnancy/lactation, and known allergies to study interventions (ICMR-DBT, 2011; Barzilai et al., 2016). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find an effective gerobiotic, millet based dietary solution for healthy aging. |
week 0 & week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/01/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Assess the effect of daily oral supplementation with
pearl millet based gerobiotic beverage on biomarkers of oxidative stress,
inflammation, brain aging and gut dysbiosis in Indian adults aged 40-65. |