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

NCT ID: NCT06122272

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-19
• Study Completion Date: 2025-05-30

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.

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test products:

New formula for healthy term infants

Group Type: EXPERIMENTAL

Test Formula

Intervention Type: 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 products

Standard, commercially available infant formula for healthy term infants

Group Type: ACTIVE_COMPARATOR

Control Formula

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Nutricia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, China

Hong Kong Center for Clinical Research

Hong Kong, , Hong Kong

Countries

China; Hong Kong

Other Identifiers

NELN202110A

Identifier Type: -

Identifier Source: org_study_id