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

NCT02410057 | Unknown

• 1 other identifier: SkaneUH
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

growth; formula; protein; alpha-lactalbumin; amino acids; metabolomics; microbiota

Outcome Measures

Primary Outcomes (1)

• Growth

  body composition

  5 years

Secondary Outcomes (3)

• Gut microbiota

  5 years

• Infection frequency

  1 year

• sleep

  2-6 months

Study Arms (4)

Standard infant formula

ACTIVE COMPARATOR

Standard infant formula

Dietary Supplement: Standard infant formula

Protein-reduced whey formula

EXPERIMENTAL

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

Dietary Supplement: Protein-reduced whey formula

Protein-reduced α-lactalbumin formula

EXPERIMENTAL

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

Dietary Supplement: Protein-reduced α-lactalbumin formula

Breast-feeding

NO INTERVENTION

Exclusive breast-feeding

Interventions

Protein-reduced α-lactalbumin formula DIETARY_SUPPLEMENT

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

Protein-reduced α-lactalbumin formula

Protein-reduced whey formula DIETARY_SUPPLEMENT

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

Protein-reduced whey formula

Standard infant formula DIETARY_SUPPLEMENT

Standard infant formula

Standard infant formula

Eligibility Criteria

• Age: 4 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants
• Born vaginally (no caecerian section)
• +0 until 42+0
• Birth weight ± 2 SD of internationally approved growth charts
• No severe neonatal problems
• No feeding problems
• No evidence of systemic disease

You may not qualify if:

• Partial breast feeding at 8 weeks
• Breast feeding in the formula Group
• Formula feeding in the breast fed Group
• Caecerian section
• Treatment with antibiotics during the first 8 weeks

Sponsors & Collaborators

• Skane University Hospital: lead
• University of California, Davis: collaborator
• Umeå University: collaborator
• Arla Foods: collaborator

Study Sites (1)

Lund University

Malmo, 205 02, Sweden

Location

Related Publications (6)

• Lonnerdal B, Lien EL. Nutritional and physiologic significance of alpha-lactalbumin in infants. Nutr Rev. 2003 Sep;61(9):295-305. doi: 10.1301/nr.2003.sept.295-305.

  PMID: 14552064 BACKGROUND

• ESPGHAN Committee on Nutrition; Agostoni C, Braegger C, Decsi T, Kolacek S, Koletzko B, Michaelsen KF, Mihatsch W, Moreno LA, Puntis J, Shamir R, Szajewska H, Turck D, van Goudoever J. Breast-feeding: A commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2009 Jul;49(1):112-25. doi: 10.1097/MPG.0b013e31819f1e05.

  PMID: 19502997 BACKGROUND

• Karlsland Akeson PM, Axelsson IE, Raiha NC. Protein and amino acid metabolism in three- to twelve-month-old infants fed human milk or formulas with varying protein concentrations. J Pediatr Gastroenterol Nutr. 1998 Mar;26(3):297-304. doi: 10.1097/00005176-199803000-00011.

  PMID: 9523865 BACKGROUND

• Axelsson IE, Jakobsson I, Raiha NC. Formula with reduced protein content: effects on growth and protein metabolism during weaning. Pediatr Res. 1988 Sep;24(3):297-301. doi: 10.1203/00006450-198809000-00004.

  PMID: 3062558 BACKGROUND

• He X, Tinghall Nilsson U, Mishchuk DO, Hernell O, Lonnerdal B, Hartvigsen ML, Jacobsen LN, Kvistgaard AS, Slupsky CM, Karlsland Akeson P. Impact of formula protein quantity and source on infant metabolism: serum, urine, and fecal metabolomes of a randomized controlled study. Am J Clin Nutr. 2025 Apr;121(4):853-864. doi: 10.1016/j.ajcnut.2025.02.002. Epub 2025 Feb 5.

  PMID: 39921093 DERIVED

• Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

  PMID: 33006765 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Pia M Karlsland Åkeson, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Consultant

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: April 7, 2015
• Study Start: November 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2024
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)