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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Test Formula; Other: Control Formula

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • The Hong Kong Polytechnic University
• Hong Kong
  • Hong Kong, Hong Kong
    • hong Kong Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test products: New formula for healthy term infants	Other: Test Formula; 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.
Active Comparator: Control products; Standard, commercially available infant formula for healthy term infants	Other: Control Formula; 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.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	weight, unit: kg	Every 6 months, up to 12 months
Length	length, unit: cm	Every 6 months, up to 12 months
BMI	BMI = weight/length2, unit: kg/cm2	Every 6 months, up to 12 months
Product intake	Study product intake: number of bottles and amount consumed per bottle	Every 6 months, up to 12 months

Collaborators and Investigators

• Sponsor: Danone Nutricia

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NELN202110A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No