None listed
Conditions
Interventions
Intervention1: Multiple-Micronutrient Nutritional Product: Dose and frequency: One serving (25 g) twice daily
Taken with: Water / Milk
Mode of administration : Per oral
Time of administration : In
Sponsors
ITC Life Sciences and Technology Center
Eligibility
Inclusion criteria
Inclusion criteria: (1) Adolescent boys and girls of 17 years and those who have not completed 18 years of age (2) Be willing to follow the scheduled visit appointments (3) Willing to provide the written informed consent of parent / guardian and assent for participation in the study (4) Subjects having past 3 months history of frequent (at least 2 times and above) upper respiratory tract infections (such as cough, sore throat, common cold, fever). History of medical condition for last 3 months will be recorded and documented.
Exclusion criteria
Exclusion criteria: (1) Participation in any nutritional research involving the food supplement or received an investigational food supplement within a period of one month prior to screening (2) Physical disability which can interfere or limit participation in the study (3) Recent history of serious infections, injuries and / or surgeries within a period of one month prior to screening (4) Subjects unable to adhere to a regular follow up schedule (5) History of any known hypersensitivity or allergy of any sort (such as asthma, eczema, atopy or allergy etc.) including food allergies like lactose intolerance that would place the subject at increased risk, as determined by the investigator(s) (6) History of alcohol, smoking, chemical, drug abuse or dependence (7) History of a systemic disorder involving the cardiovascular, respiratory renal, gastrointestinal, hepatic, immunologic hematological, endocrine, autoimmune immunodeficiency (e.g., human immunodeficiency virus [HIV] infection), or nervous system(s (8) Any antibiotic use in the past one week prior to entering the study (9) History of vaccination such as seasonal influenza vaccine in the past 2 months (10) Subjects taking health supplements (11) Subjects with deteriorating health status at the time of enrollment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhea, irritable bowel syndrome etc.) (12) Pregnancy, breast feeding and females planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in general illness (assessed by immune biomarkers)Timepoint: at the end of Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of a study product by analyzing the incidence of adverse eventsTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactMr Vijay Bhaskar
Semler Research Center Pvt Ltd
Outcome results
None listed