Status:
COMPLETED
An Exploratory Trial in Hong Kong to Explore the Effect of a New Formula
Lead Sponsor:
Danone Nutricia
Conditions:
Healthy Subjects
Eligibility:
All Genders
6-6 years
Phase:
NA
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 fe...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06122272
Start Date
December 19 2023
End Date
May 30 2025
Last Update
August 5 2025
Active Locations (2)
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1
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, China
2
Hong Kong Center for Clinical Research
Hong Kong, Hong Kong