Clinical trial NCT05757323: The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
First posted: 2023-03-07
Enrollment: 345
Sex: ALL
Minimum age (years): 5
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: weight gain
timeFrame: until 17 weeks of age
Secondary outcomes:
measure: Weight
timeFrame: until 17 weeks of age
measure: Length
timeFrame: until 17 weeks of age
measure: head circumference
timeFrame: until 17 weeks of age
measure: BMI
timeFrame: until 17 weeks of age
measure: WAZ
timeFrame: until 17 weeks of age
measure: LAZ
timeFrame: until 17 weeks of age
measure: WHZ
timeFrame: until 17 weeks of age
measure: BMI-for-age Z-score
timeFrame: until 17 weeks of age
measure: head circumference-for-age Z-score
timeFrame: until 17 weeks of age
Other outcomes:
measure: formula intake
timeFrame: until 17 weeks of age
Locations:
city: Tríkala
country: Greece
facility: Department of Nutrition and Dietetics, University of Thessaly
state: Thessaly
city: Athens
country: Greece
facility: Harokopio University
city: Thessaloníki
country: Greece
facility: Department of Nutritional Sciences, International Hellenic University
Study officials:
affiliation: Harokopio University
name: Yannis Manios, Prof
role: PRINCIPAL_INVESTIGATOR
References: