Trials / Completed
CompletedNCT05757323
The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 345 (actual)
- Sponsor
- FrieslandCampina · Industry
- Sex
- All
- Age
- 5 Days – 28 Days
- Healthy volunteers
- Accepted
Summary
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.
Detailed description
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | infant formula based on hydrolyzed protein | infant formula based on hydrolysed protein |
| OTHER | infant formula based on intact protein | infant formula based on intact protein |
Timeline
- Start date
- 2021-08-06
- Primary completion
- 2022-10-24
- Completion
- 2022-10-24
- First posted
- 2023-03-07
- Last updated
- 2023-09-22
Locations
3 sites across 1 country: Greece
Source: ClinicalTrials.gov record NCT05757323. Inclusion in this directory is not an endorsement.