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

Healthy Subjects Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122272
• Other study ID #: NELN202110A
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Danone Nutricia
• Contact: Camille YU, PM
• Phone: 008618817338946
• Email: camille.yu[@]danone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong	Hong Kong
Hong Kong	Hong Kong Center for Clinical Research	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Danone Nutricia

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	weight, unit: kg	Every 6 months, up to 12 months
Other	Length	length, unit: cm	Every 6 months, up to 12 months
Other	BMI	BMI = weight/length2, unit: kg/cm2	Every 6 months, up to 12 months
Other	Product intake	Study product intake: number of bottles and amount consumed per bottle	Every 6 months, up to 12 months
Primary	Body composition	Fat mass (kg)	Every 6 months, up to 12 months