None listed
Conditions
Interventions
Intervention1: Functional Food Product: 200 ml/day for 365 days
Control Intervention1: Premix product: 200 ml/day for 365 days
Sponsors
ITC Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the safety of functional food product in healthy adult volunteers.Timepoint: 3, 6, 9, 12 months | — |
Countries
India
Contacts
Public ContactMr T Vijay Bhaskar
Semler Research Center Pvt Ltd
Outcome results
None listed