Acceptability and Tolerance Study of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children

Nutrition Disorder, Child Clinical Trial

Official title: Evaluation of the Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a High Energy Peptide Based Paediatric Oral Nutritional Supplement for Children Over 12 Months of Age

Status Completed

Clinical Trial Summary

This is an acceptability study (including gastrointestinal tolerance, compliance and palatability) of a high energy peptide based paediatric oral nutritional supplement for children over 12 months of age.

The acceptability data from a minimum of 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Clinical Trial Description

Fifteen (15) participants, aged 12 months and over, requiring a high energy peptide based oral nutritional supplement drink for the dietary management.

The ACBS requirement for evaluable data on 15 participants has informed the trial's recruitment target; however, we may need to exceed this target if any patients give their consent to join the study but then decide not to participate in the study. Participants who join the study and begin using the product would count towards the recruitment total and their data would be included in a submission to the ACBS whether they complete the 7-day study period or not.

Each potential participant must meet all of the inclusion criteria and not meet any of the exclusion criteria. ;

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorder, Child
• Nutrition Disorders

• NCT number: NCT04515940
• Study type: Observational
• Source: Nestlé
• Status: Completed
• Start date: October 30, 2019
• Completion date: September 29, 2020