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

Danone

Status: Enrolling

Conditions: Healthy Subjects

Treatments: Other: Control Formula; Other: Test Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT06122272

NELN202110A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 6 to 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Test products:

Experimental group

Description:

New formula for healthy term infants

Treatment:

Other: Test Formula

Control products

Active Comparator group

Description:

Standard, commercially available infant formula for healthy term infants

Treatment:

Other: Control Formula