Growth and Metabolism in Infants Fed Protein-reduced, Alpha-lactalbumin Enriched Formula

Summary

Formula composition is developed to resemble breast milk as close as possible, but there are still considerable differences between formula and breast milk composition, probably resulting in higher risk of overweight in childhood and higher incidence of infections in formula-fed infants. Protein levels are still higher and constituents such as alpha-lactalbumin lower in formula than in breast milk. By adding more alpha-lactalbumin to formula, rich in tryptophan, the resulting amino acid composition will allow further reduction of protein in formula. The investigators intend to include 320 infants, where 80 will be exclusively breastfed and the remainder assigned in a double blind, controlled, randomized manner to one of three formula groups; two experimental, protein reduced formula with two different levels of alpha-lactalbumin and one group given standard infant formula. The intervention period is from 4-8 weeks until 6 months of age. The infants will be followed by growth parameters, blood-, urine- and fecal biomarkers and health parameters until 5 years of age. The experimental formula will possibly result in growth, metabolism and gut microbiota as well as health parameters more similar to those of breastfed infants

Conditions

• Growth
• Infection
• Sleep

Interventions

DIETARY_SUPPLEMENT

Protein-reduced α-lactalbumin formula

Protein-reduced formula with levels of α-lactalbumin more similar to breast milk and higher than in whey formula and in standard infant formula

DIETARY_SUPPLEMENT

Protein-reduced whey formula

Protein-reduced whey formula with higher levels of α-lactalbumin than in standard infant formula

DIETARY_SUPPLEMENT

Standard infant formula

Standard infant formula

Sponsors & Collaborators

• University of California, Davis

  collaborator OTHER

• Umeå University

  collaborator OTHER

• Arla Foods

  collaborator INDUSTRY

• Skane University Hospital

  lead OTHER

Principal Investigators

• Pia M Karlsland Åkeson, MD, PhD · Lund University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Weeks

Max Age

8 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2020-04-30

Completion

2024-12-31

Countries

• Sweden

Study Locations