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

NCT06122272 | Completed

• 1 other identifier: NELN202110A
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Body composition

  Fat mass (kg)

  Every 6 months, up to 12 months

Other Outcomes (4)

• Weight

  Every 6 months, up to 12 months

• Length

  Every 6 months, up to 12 months

• BMI

  Every 6 months, up to 12 months

Study Arms (2)

Test products:

EXPERIMENTAL

New formula for healthy term infants

Other: Test Formula

Control products

ACTIVE COMPARATOR

Standard, commercially available infant formula for healthy term infants

Other: Control Formula

Interventions

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.

Test products:

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.

Control products

Eligibility Criteria

• Age: 6 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Nutricia: lead

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, China

Location

Hong Kong Center for Clinical Research

Hong Kong, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: November 8, 2023
• Study Start: December 19, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-03

Locations

HK (1); CN (1)