The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants

Not Applicable

Completed

• Conditions: Growth

• Registration Number: NCT05757323
• Lead Sponsor: FrieslandCampina

Brief 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.

Study Timeline

• Study Start: 2021-08-06
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-03-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
weight gain	until 17 weeks of age	weight gain in g/day

Secondary Outcome Measures

Name	Time	Method
WAZ	until 17 weeks of age	weight-for-age Z-score
head circumference-for-age Z-score	until 17 weeks of age	head circumference-for-age Z-score
Weight	until 17 weeks of age	Weight in g
head circumference	until 17 weeks of age	head circumference in cm
BMI	until 17 weeks of age	BMI in kg/m2
LAZ	until 17 weeks of age	length-for-age Z-score
BMI-for-age Z-score	until 17 weeks of age	BMI-for-age Z-score
Length	until 17 weeks of age	length in cm
WHZ	until 17 weeks of age	weight-for-height Z-score

Trial Locations

Locations (3)

Department of Nutrition and Dietetics, University of Thessaly; 🇬🇷 Tríkala, Thessaly, Greece

Harokopio University; 🇬🇷 Athens, Greece

Department of Nutritional Sciences, International Hellenic University; 🇬🇷 Thessaloníki, Greece