NCT05757323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

February 24, 2023

Last Update Submit

September 21, 2023

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • weight gain

    weight gain in g/day

    until 17 weeks of age

Secondary Outcomes (9)

  • Weight

    until 17 weeks of age

  • Length

    until 17 weeks of age

  • head circumference

    until 17 weeks of age

  • BMI

    until 17 weeks of age

  • WAZ

    until 17 weeks of age

  • +4 more secondary outcomes

Other Outcomes (1)

  • formula intake

    until 17 weeks of age

Study Arms (2)

test formula

EXPERIMENTAL

hydrolysed protein-based infant formula

Other: infant formula based on hydrolyzed protein

control formula

ACTIVE COMPARATOR

standard intact protein-based formula

Other: infant formula based on intact protein

Interventions

infant formula based on hydrolyzed proteinOTHER

infant formula based on hydrolysed protein

test formula
infant formula based on intact proteinOTHER

infant formula based on intact protein

control formula

Eligibility Criteria

Age5 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Nutrition and Dietetics, University of Thessaly

Trikala, Thessaly, 42132, Greece

Location

Harokopio University

Athens, Thiseos 70, Kallithea 176 71, Greece

Location

Department of Nutritional Sciences, International Hellenic University

Thessaloniki, 55535, Greece

Location

Related Publications (1)

  • Kantaras P, Kokkinopoulou A, Hageman JHJ, Hassapidou M, Androutsos O, Kanaki M, Bovee-Oudenhoven I, Karaglani E, Kontochristopoulou AM, Bos R, Manios Y. Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant formula: a randomized controlled double-blind trial. Front Pediatr. 2024 May 17;12:1328709. doi: 10.3389/fped.2024.1328709. eCollection 2024.

    PMID: 38827219DERIVED

Related Links

Study Officials

  • Yannis Manios, Prof

    Harokopio University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

August 6, 2021

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

GR(3)