Exploring the effects of a new formula on healthy infants
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 study tests a new feeding formula for healthy infants aged 6 months to see if it helps with growth and body composition compared to a regular formula.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 6 Months to 6 Months |
| Sex | All |
| Sponsor | Danone Nutricia Industry-sponsored |
| Locations | 2 sites (Hong Kong, Hong Kong and 1 other locations) |
| Trial ID | NCT06122272 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to investigate the health benefits of a new feeding formula in healthy infants aged 6 months. The study compares the effects of the test formula against a control formula, focusing on body composition and growth parameters. Additionally, it assesses safety, tolerance, and user experience related to the feeding product. The findings may help generate hypotheses for future research on infant nutrition.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy, singleton, term-born infants aged 6 months who are currently fed with formula.
Not a fit: Infants with special dietary needs, allergies to cow's milk, fish, or soy, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal nutrition for infants, potentially improving growth and health outcomes.
How similar studies have performed: While exploratory studies on infant nutrition are common, the specific approach of this study may offer novel insights, though similar studies have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong, Hong Kong and 1 other locations
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong, China (Not_yet_recruiting)
- Hong Kong Center for Clinical Research — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Camille YU, PM
- Email: camille.yu@danone.com
- Phone: 008618817338946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.