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

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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)

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

Trial contacts and locations

2

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Central trial contact

Camille YU, PM

Data sourced from clinicaltrials.gov

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