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Completed

NCT Number: NCT06122272

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

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.

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Key information

Conditions

Age range

6 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University, Hong Kong, China

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test formula

Other

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.

Control Formula

Other

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.

Primary outcomes

  1. Body composition

    Time frame: Every 6 months, up to 12 months

    Fat mass (kg)

Other outcomes

  1. Weight

    Time frame: Every 6 months, up to 12 months

    weight, unit: kg

  2. Length

    Time frame: Every 6 months, up to 12 months

    length, unit: cm

  3. BMI

    Time frame: Every 6 months, up to 12 months

    BMI = weight/length2, unit: kg/cm2

  4. Product intake

    Time frame: Every 6 months, up to 12 months

    Study product intake: number of bottles and amount consumed per bottle

Sponsors and collaborators

Lead sponsor

Danone Nutricia

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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