None listed
Conditions
Interventions
Intervention1: NE-S01: Subjects will be advised to consume 200 ml NE-S01 orally throughout day for 14 days as a nutritional supplement.
Control Intervention1: NIL: NIL
Sponsors
Naturedge Beverages Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Child is > or equal to 5 years and 2) Child of either gender (Male and Female). 3) Child has a weight-for-height between 3rd â?? 15th percentiles according to current WHO Growth Charts at visit 1. (WHO Growth Chart 2007) 4)Child is a picky eater, defined as meeting at least two of the following criteria. A child, who a.eats only a limited number of foods b.is unwilling to try new foods c.refuses to eat vegetables and/or foods from other food groups d.shows strong food likes and dislikes e.has behaviors that disrupt mealtime 5) Child is able to consume foods and beverages orally. 6)Childâ??s LG or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period. 7)Childâ??s LG or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study. 8)Childâ??s LG or parent(s)is not planning to relocate during the study period
Exclusion criteria
Exclusion criteria: The subjects will be excluded based on the following criteria during screening and during the study. 1)Child has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or LG/parent report. 2)Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or LG/parent report. 3)Child has a current acute or chronic infection including but not restricted to respiratory infection, diarrhea, Hepatitis B or C, HIV infection or tuberculosis according to medical records or LG/parent report based on the clinicianâ??s judgment. 4)Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or LG/parent report. 5)Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or LG/parent report. 6)Child has been diagnosed with hormonal or metabolic disorders according to medical records or LG/parent report. 7)Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Downâ??s syndrome according to medical records or LG/parent report. 8)Child has been diagnosed with infantile anorexia nervosa according to medical records or LG/parent report. 9)Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or LG/parent report. 10)Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or LG/parent report. 11)Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator. 12)Child has any other clinically significant medical condition, which in the investigatorâ??s opinion, makes him or her unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Apetite score at baseline and end of study 2.Children Happiness Score at baseline and end of study 3.Palatability Score at baseline and end of study Timepoint: Baseline, Visit 1 (Day 7), Visit 2 (Day 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Tolerance of NE-S01 by patients 2.Global evaluation for overall improvement by physician and subject 3.Adverse events Timepoint: Baseline, Visit 1 (Day 7), Visit 2 (Day 14) | — |
Countries
India
Contacts
Public ContactDr Veena Deo
Naturedge Beverages Pvt. Ltd.
Outcome results
None listed