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

Not Applicable

Recruiting

• Conditions: Healthy Subjects
• Interventions: Other: Test Formula; Other: Control Formula

• Registration Number: NCT06122272
• Lead Sponsor: Danone Nutricia

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.

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-08
• Study Start: 2023-12-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test products:	Test Formula	New formula for healthy term infants
Control products	Control Formula	Standard, commercially available infant formula for healthy term infants

Primary Outcome Measures

Name	Time	Method
Body composition	Every 6 months, up to 12 months	Fat mass (kg)

Trial Locations

Locations (2)

Hong Kong Center for Clinical Research; 🇭🇰 Hong Kong, Hong Kong

The Hong Kong Polytechnic University; 🇨🇳 Hong Kong, Hong Kong, China