| CTRI Number |
CTRI/2020/03/023865 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
21/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [safety and efficacy study] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Test Products on Immune Markers and Gut Health In Elderly Population |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-Blind, Placebo-Controlled, Comparative Study to Determine Effects of Synbiotic Test Product on Immune Markers and Gut Health In Elderly Population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KLS19-TCL-254, Version no. 00, Date 19 Feb 20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No. 7,
Opp. Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone 91-79-68221100
Fax 91-79-66219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No. 7,
Opp. Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone 91-79-68221100
Fax 91-79-66219549
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maheshvari Patel |
| Designation |
Associate Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No. 7,
Opp. Auda Garden,
Bodakdev, Ahmedabad 380054, India
Phone 91-79-68221100
Fax 91-79-66219549
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013236 |
| Fax |
07966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Chemicals Ltd |
| Address |
Survey No 315
Hissa No 1-14
Ambedveth
Paud Rd
Mulshi
Pune, Maharashtra 412111
Phone 020 6654 9700
Fax 020 66549735 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No. 7
Opp. Auda Garden
Bodakdev
Ahmedabad 380054
India
Phone 917968221100
Fax 917966219549
Ahmadabad
GUJARAT |
9909013286
07966219549
nkpatel@cliantha.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| OM |
Approved |
| OM |
Approved |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteer’s complaining of frequent infections as cough/cold and other upper respiratory tract infections |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Test Product 1: (Prebiotics in Dry Milk Powder) Supplied By: Tata Chemicals Ltd.
Test Product 2: (Probiotics in Dry Milk Powder) Supplied By: Tata Chemicals Ltd.
Test Product 3: (Pre and Pro Combination in Dry Milk Powder) Supplied By: Tata Chemicals Ltd. |
Each subject will consume test product twice a day as per randomization schedule. 1 sachet (10 gm) in the morning and 1 sachet (10 gm) in the evening. Test product to be added in 100 mL water in room temperature, mix properly and consume. |
| Comparator Agent |
Test Product 1: Placebo (Dry Milk Powder) Supplied by: Tata Chemicals Ltd. |
Each subject will consume test product twice a day as per randomization schedule. 1 sachet (10 gm) in the morning and 1 sachet (10 gm) in the evening. Test product to be added in 100 mL water in room temperature, mix properly and consume. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 50 to 65 years (both inclusive) old at the time of consent.
2) Subjects with BMI: In between 18.5 to 27.5 kg/m2.
3) Gender: Male or females (Post menopausal female with history at least one year of amenorrhea).
4) Subjects who are sensitive to weather change, cold, cough, fever, sore throat/throat infection etc. by medical history.
5) Subjects with generally good health conditions, free from any disease condition to affect their dietary intake.
6) Subjects with no known side effect/allergy or intolerance to milk, Probiotic, prebiotic or synbiotics or any similar products/food/food ingredients.
7) Subjects must be able to understand and provide written informed consent to participate in the study.
8) Subjects should be willing and able to follow the study protocol to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) Subjects with current use or use in the past 3 months of antimicrobial or steroidal drugs or any prescription medication.
2) Subjects who are not ready to refrain from taking fermented foods like dosa, idly, butter milk, curd, any other supplements (Prebiotic, probiotic, synbiotics etc.) during this study period as well at least 2 week before enrollment. (Refer attached appendix IV).
3) Subjects who are taking fiber supplement or any micronutrient supplement during this study period as well at least 2 week before enrollment.
4) Subjects with medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV) or taking medicine which may have impacts on immune system like antibiotics, antimicrobial, probiotic sachets.
5) Subjects with known history of Diabetes (any form) or any other disease condition which affect their daily dietary intake.
6) History of drug and alcohol abuse.
7) Participation in a similar clinical study within the previous 90 days.
8) Any surgical treatment previous three months or planned during the study.
9) Any subject in the Principal investigators opinion not considered suitable for enrollment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To assess the effect of test product and control products on mean % change in immunity markers by measuring NK cell activity.
2. To assess the effect of test product and control products on mean % change in immunity markers i.e. Cytokines level (IFN-g, IL-1 Beta, IL-10, IL-17 and TNF-alpha).
3.To assess the effect of test product and control products in terms of change in gut microbes by NGS in feces.
|
1. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups.
2. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups.
3. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products’ groups.
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. To assess the effect of test product and control products on change in the occurrence of cold/ cough frequency by asking questions to subjects. |
1.Baseline i.e. Day 1 before administration of products to Day 90. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="199" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2020 |
| Date of Study Completion (India) |
29/09/2020 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparative Study to
Determine Effects of Prebiotic, Probiotics, Symbiotic and Placebo Test Products
on Immune Markers and Gut Health In Elderly Population. Test products will be
tested against controls involving 120 subjects. Total study duration is 90
days. |