Clinical trial NCT05578716: Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula
Official title: GRANDIOSA - Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Formula
Keywords: Infant nutrition
Food hypersensitivity
Dermatitis, Atopic
Protein hydrolysates
Spectroscopy, Near-Infrared
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Lund University
name: Arla Foods
First posted: 2022-10-13
Enrollment: 312
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to either standard formula or one of two partially hydrolysed study formulae. Included in the study will also be a group of breast-fed infants acting as reference group.
Primary purpose: PREVENTION

Brief summary: Breastfeeding is the recommended diet for all infants during the first half of infancy and is associated with numerous health benefits. However, when breastfeeding is not possible, an infant formula is the only nutritive alternative. Formula-fed infants have a different growth pattern compared to breastfed infants. Studies have shown that the higher protein content in infant formula compared to breastmilk results in a more rapid weight gain and an increased risk of overweight and obesity in childhood. For this reason, both quantity and quality of protein in infant formulae have been optimized during the last decade, to better meet the needs of infants and to support growth close to that of breastfed infants.

Protein hydrolysis, a common modification of infant formulae, has originally been developed for treatment of cow's milk protein allergy. Certain hydrolysed formulae have been suggested to prevent atopic eczema when given to infants with a family history of allergic disease but as of yet, the allergy preventive effect in infants without increased risk of allergic disease has been little studied. Partially hydrolysed infant formulae have also been suggested to reduce common functional gastrointestinal symptoms in infants.

New protein hydrolysates are continually developed for use in infant formulae, with the aim of reducing allergenicity, while ensuring optimal growth and development of infants. It is important to study the effects on growth and health outcomes in infants who are fed formulae based on these newly developed hydrolysates as compared to those fed standard intact protein formulae or breastmilk.

The overall aims of the current study are to evaluate the effects of two new hydrolysates on growth, immunological biomarkers, neurodevelopment, protein metabolism and gut microbiota in a randomized, controlled clinical trial of healthy infants. In compliance with European Food Safety Authority (EFSA) regulations for novel infant formulas based on hydrolysed protein, the primary outcome is change in weight standard deviation score (SDS) from baseline until 5 months of age.


Eligibility criteria: Inclusion Criteria:

* Healthy infants born at term
* Birth weight 2500 to 4500 gram
* Either exclusive breast-feeding (reference group) or exclusive formula-feeding (intervention and control group)

Exclusion Criteria:

* Suspected or verified food allergy
* Suspected or verified infant colic

Primary outcomes:
measure: Weight
timeFrame: At 5 months of age
Secondary outcomes:
measure: Length.
timeFrame: At enrollment at 2 months of age and monthly during the intervention up to 5 months of age.
measure: Head circumference.
timeFrame: At enrollment at 2 months of age and monthly during the intervention up to 5 months of age.
measure: Body composition
timeFrame: At 4 months of age
measure: Gastrointestinal tolerance.
timeFrame: At enrollment at 2 months of age and during the intervention up to 5 months of age.
measure: Gastrointestinal immunology.
timeFrame: At enrollment at 2 months of age and during the intervention up to 5 months of age.
measure: Eczema severity, parent report.
timeFrame: At enrollment at 2 months of age and during the intervention up to 5 months of age.
measure: Eczema severity, clinical assessment.
timeFrame: At enrollment at 2 months of age and during the intervention up to 5 months of age.
measure: Allergy.
timeFrame: At enrollment at 2 months of age and at the end of the intervention at 5 months of age.
measure: Immunologic activity.
timeFrame: At enrollment at 2 months of age and at the end of the intervention at 5 months of age.
measure: Metabolic biomarkers in blood.
timeFrame: At enrollment at 2 months of age and at the end of the intervention at 5 months of age.
measure: Markers of protein metabolism.
timeFrame: At enrollment at 2 months of age and at the end of the intervention at 5 months of age.
measure: Microbiota
timeFrame: At enrollment at 2 months of age and during the intervention up to 5 months of age.
measure: Neurodevelopment at 6 months of age.
timeFrame: At 6 months of age.
measure: Neurodevelopment at 12 months of age.
timeFrame: At 12 months of age.
measure: Neurodevelopment at 3 years of age.
timeFrame: At 3 years of age
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of clinical science, Preventive Paediatrics, Lund university
city: Umeå
country: Sweden
facility: Department of Clinical Sciences, Pediatrics, Umeå University Hospital
Study officials:
affiliation: Department of Clinical Sciences, Pediatrics, Umeå University Hospital
name: Magnus Domellöf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: