Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula (GRANDIOSA)

Umeå University

Status: Enrolling

Conditions: Infant Formula

Treatments: Dietary Supplement: Partially hydrolysed formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05578716

20210707401

Details and patient eligibility

About

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.

Enrollment: 312 estimated patients

Sex: All

Ages: 4 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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312 participants in 4 patient groups

Study formula 1

Experimental group

Description:

Formula-fed intervention group randomised to one of two study formulae

Treatment:

Dietary Supplement: Partially hydrolysed formula

Study formula 2

Experimental group

Description:

Formula-fed intervention group randomised to one of two study formulae

Treatment:

Dietary Supplement: Partially hydrolysed formula

Standard formula

No Intervention group

Description:

Formula-fed control group randomised to standard formula

Breast feeding

No Intervention group

Description:

Reference group with exclusively breast-fed infants