Clinical trial NCT06122272: An Exploratory Trial in Hong Kong to Explore the Effect of a New Formula
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Danone Nutricia
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Body composition
timeFrame: Every 6 months, up to 12 months
Secondary outcomes:
Other outcomes:
measure: Weight
timeFrame: Every 6 months, up to 12 months
measure: Length
timeFrame: Every 6 months, up to 12 months
measure: BMI
timeFrame: Every 6 months, up to 12 months
measure: Product intake
timeFrame: Every 6 months, up to 12 months
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
state: Hong Kong
city: Hong Kong
country: Hong Kong
facility: Hong Kong Center for Clinical Research
Study officials:
References: