Effect of Test Products on Immune Markers and Gut Health In Elderly Populatio

Not Applicable

Completed

• Registration Number: CTRI/2020/03/023865
• Lead Sponsor: Tata Chemicals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-29
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 199

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the effect of test product and control products on mean % change in immunity markers by measuring NK cell activity. <br/ ><br> <br/ ><br>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). <br/ ><br> <br/ ><br>3.To assess the effect of test product and control products in terms of change in gut microbes by NGS in feces. <br/ ><br>Timepoint: 1. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products� groups. <br/ ><br> <br/ ><br>2. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products� groups. <br/ ><br> <br/ ><br>3. Baseline i.e. Day 1 before administration of products to Day 45 and Day 90 also between the test and control products� groups. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
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.Timepoint: 1.Baseline i.e. Day 1 before administration of products to Day 90.