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

April 1, 2024 updated by: Danone Nutricia

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Not yet recruiting
        • The Hong Kong Polytechnic University
        • Contact:
          • Jiachi, Amber Chiou, Dr.
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Center for Clinical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Every 6 months, up to 12 months
Fat mass (kg)
Every 6 months, up to 12 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Nutricia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

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)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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