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

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757323
• Other study ID #: HerA
• Status: Completed
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: October 24, 2022

Study information

• Verified date: September 2023
• Source: FrieslandCampina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• infant formula based on hydrolyzed protein
infant formula based on hydrolysed protein
• infant formula based on intact protein
infant formula based on intact protein

Locations

Country	Name	City	State
Greece	Harokopio University	Athens
Greece	Department of Nutritional Sciences, International Hellenic University	Thessaloníki
Greece	Department of Nutrition and Dietetics, University of Thessaly	Tríkala	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
FrieslandCampina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	formula intake	formula intake in ml	until 17 weeks of age
Primary	weight gain	weight gain in g/day	until 17 weeks of age
Secondary	Weight	Weight in g	until 17 weeks of age
Secondary	Length	length in cm	until 17 weeks of age
Secondary	head circumference	head circumference in cm	until 17 weeks of age
Secondary	BMI	BMI in kg/m2	until 17 weeks of age
Secondary	WAZ	weight-for-age Z-score	until 17 weeks of age
Secondary	LAZ	length-for-age Z-score	until 17 weeks of age
Secondary	WHZ	weight-for-height Z-score	until 17 weeks of age
Secondary	BMI-for-age Z-score	BMI-for-age Z-score	until 17 weeks of age
Secondary	head circumference-for-age Z-score	head circumference-for-age Z-score	until 17 weeks of age

External Links

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