None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children Aged 0-16 years inclusive (both gender) Participants will be equally distributed to age range from 0-5 years (Both inclusive) 5 plus to 10 years (Both inclusive) and 10 plus to 16 years (Both inclusive) that is 10 participants in each category. 2.Parents or guardians understand and are willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1.Participant has a known allergy or intolerance to the study product or ingredients or is on a special diet and cannot consume the study product. 2.The participant has an ongoing illness requiring medical management. 3.The participant has a gastrointestinal infection and or acute diarrhea at the time of inclusion in the study. 4.The participant is currently taking medication that could affect the absorption or metabolism of the study product or the weight of the child. 5.The participant is diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes congenital abnormalities of the respiratory tract congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma (As per history and or the medical records). 6.Any other condition that could interfere with the study outcomes as per the discretion of the investigator will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in physical growth parameters •Anthropometric parameters like height, body weight upper arm & chest circumference, and BMI.Timepoint: screening, day 30, day 60, and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Effect on Immunological parameters like- •Serum Immunoglobulin A, G levels •Changes in frequency severity and recovery of URTI 2.cardiorespiratory fitness- VO2 and Pre-school adapted 20m Shuttle run test (PREFIT). 3.Learning ability memory and concentration- Questionnaire for Evaluation of Development and Behaviour (Parent version)- Attention and concentration memory reading writing arithmetic learning new things and applying knowledge in school domain scores will be analyzed. 4.Quality of sleep- Pittsburgh Sleep Quality Index (PSQI) will be assessed. 5.Change in appetite score using the child eating behaviour questionnaire (CEBQ). 6.Parent or Guardian reported an overall improvement in child growth and development after treatment on the 5-point Likert scale. Timepoint: screening and end of the study screening, day 30, day 60, and day 90. screening and day 90 (Only for groups B and C) screening and day 90 screening and day 90 screening, day 30, day 60, and day 90 day 90 | — |
Countries
India
Contacts
Vasu Healthcare Pvt Ltd