A clinical study of a functional food product on immunity in healthy adults

Not Applicable

Completed

• Registration Number: CTRI/2017/09/009893
• Lead Sponsor: ITC Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Healthy subjects of either sex aged 18 to 60 years

No antibiotics use within 2 months prior to entering the study or during the study

Not been vaccinated with current seasons influenza vaccine

Subjects able to provide written informed consent

Agree to receive a flu vaccine

If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the study

Exclusion Criteria

Subjects with deteriorating health status at the time of enrolment; rapid weight loss, terminal disease, significant chronic disease (example chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome)

Recent blood donation (within 3 months from the date of screening)

Immunodeficiency disease (example human immunodeficiency virus [HIV] infection)

History of allergy, lactose intolerance, prior serious reaction to influenza vaccine, medication or supplement use that influences the immune system

Pregnant or breast feeding women

Currently participating or having participated in another clinical trial during the last three months prior to the beginning of this study

Conditions in the opinion of the investigator make the patient unsuitable to participate in the study

Any contraindication to blood sampling

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate the efficacy of functional food product for modulating the immune health in healthy adult volunteers.Timepoint: 3, 6, 9, 12 months

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to evaluate the safety of functional food product in healthy adult volunteers.Timepoint: 3, 6, 9, 12 months