An Exploratory, Randomised, Open Label, Controlled, Multicentre Clinical Trial in Hong Kong to Explore the Effect of a New Nutritional Formula on Body Composition and Other Health Outcomes in Early Life.

Danone Nutricia2 sites in 2 countries180 target enrollmentDecember 19, 2023

ConditionsHealthy Subjects

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: Danone Nutricia
Enrollment: 180
Locations: 2
Primary Endpoint: Body composition
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an exploratory study with the aim to gain insight and potentially generate hypotheses on health benefits of feeding with study product. This study explores in healthy subjects the effect of feeding with the test product compared to the control product in early life.

Detailed Description

* Key exploratory objective is to find an effect on body composition. * Other exploratory objectives are to find an effect on growth parameters. * Safety and tolerance and the user experience will be investigated.

Registry

clinicaltrials.gov

Start Date

December 19, 2023

End Date

May 30, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Danone Nutricia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, singleton, term born infants.
•Infants aged 6 months(± 2 weeks) at enrolment.
•Infants fed with formula (with or without additional weaning foods or drinks) before enrolment.
•Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.

Exclusion Criteria

•Infants who require a special diet other than Formula with intact cow's milk protein.
•Infants known or suspected to have cow's milk, fish protein, and/or soy allergy and/or lactose intolerance.
•Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
•Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
•Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements.
•Employees and/or infants/family members or relatives of employees of Danone Nutricia, the participating sites, or any other nutrition company that develops Infant, Follow On or Young Child formulae.