An Exploratory Trial in Hong Kong to Explore the Effect of a New Formula

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Test Formula
* Other: Control Formula


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test products:<br>New formula for healthy term infants | Other: Test Formula<br>* The duration of the study for each subject from enrolment to final visit, is 12 months. Test Formula will be provided during this 12 month.<br>|
| Active Comparator: Control products<br>Standard, commercially available infant formula for healthy term infants | Other: Control Formula<br>* The duration of the study for each subject from enrolment to final visit, is 12 months. Control Formula will be provided during this 12 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Fat mass (kg) | Every 6 months, up to 12 months |