NCT06122272

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Danone Nutricia · Industry
• Sex: All
• Age: 6 Months – 6 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-12-19
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-11-08
• Last updated: 2025-08-05

Locations

2 sites across 2 countries: China, Hong Kong