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

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.

Study Overview

• Status: Completed
• Conditions: Growth
• Intervention / Treatment: Other: infant formula based on hydrolyzed protein; Other: infant formula based on intact protein

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 Type: Interventional
• Enrollment (Actual): 345
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, Thiseos 70, Kallithea 176 71
    • Harokopio University
  • Thessaloníki, Greece, 55535
    • Department of Nutritional Sciences, International Hellenic University
  • Thessaly
    • Tríkala, Thessaly, Greece, 42132
      • Department of Nutrition and Dietetics, University of Thessaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Full-term infants (born at gestational age =37 weeks).
• Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
• Boys and girls
• Apparently healthy at birth and screening
• Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
• Age at enrolment: =28 days of age
• Exclusively formula fed for at least 5 days prior to inclusion
• Exclusively formula fed during the entire intervention period
• Parents agreeing to initiate complementary feeding after finalization of the study
• Being available for follow up until the age of approximately 3.5 months
• Written informed consent from parent(s) and/or legal guardian(s) aged =18 years

Exclusion criteria:

• Gestational age <37 weeks
• Birth weight <2500 g or >4200 g
• Age at enrolment: >28 days
• Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
• Illness at screening/inclusion
• Incapability of parents to comply with the study protocol
• Illiterate parents (i.e. not able to read and write in local language)
• Participation in another clinical trial
• Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
• infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test formula; hydrolysed protein-based infant formula	Other: infant formula based on hydrolyzed protein; infant formula based on hydrolysed protein
Active Comparator: control formula; standard intact protein-based formula	Other: infant formula based on intact protein; infant formula based on intact protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight gain	weight gain in g/day	until 17 weeks of age

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
formula intake	formula intake in ml	until 17 weeks of age

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Investigators: Principal Investigator: Yannis Manios, Prof, Harokopio University

Publications and helpful links

Helpful Links

• first registration of the trial (register is closed, so not able to enter new data)

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): October 24, 2022
• Study Completion (Actual): October 24, 2022

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Hera

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No