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

FrieslandCampina

Status: Completed

Conditions: Growth

Treatments: Other: infant formula based on intact protein; Other: infant formula based on hydrolyzed protein

Study type: Interventional

Funder types: Industry

Identifiers

NCT05757323

HerA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 345 patients

Sex: All

Ages: 5 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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345 participants in 2 patient groups

test formula

Experimental group

Description:

hydrolysed protein-based infant formula

Treatment:

Other: infant formula based on hydrolyzed protein

control formula

Active Comparator group

Description:

standard intact protein-based formula

Treatment:

Other: infant formula based on intact protein