Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function

Summary

Breast milk is the gold standard of early infant nutrition and breastfed infants have advantages in several short and long term outcomes compared to those formula-fed.

The first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant formula. The general hypothesis is that bovine lactoferrin reduces some of the previously observed differences between formula-fed and breast-fed infants with regard to health and development. The main outcome studied is the effect on immune function. The second aim is to study the effects of lower iron concentration in infant formula and to test the hypothesis that iron can be lowered without negative effects on health and development. The main outcome studied here is iron status. Other outcomes in this trial are microbiota composition, metabolomics, growth, body composition and cognitive development.

To test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron (2 mg/L) control formula, or the same formula supplemented with bovine lactoferrin. To test the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher iron concentration (8 mg/L). Group allocation for all formula-fed infants will be double-blind randomized. Additionally, breast-fed infants will be recruited and used as a reference group (gold standard).

Conditions

• Health of Formula-fed Children
• Infant Infections in Formula-fed Children
• Iron Status of Formula-fed Children

Interventions

DIETARY_SUPPLEMENT

Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin

DIETARY_SUPPLEMENT

Formula with low iron concentration (2mg/L) without lactoferrin

DIETARY_SUPPLEMENT

Formula with normal iron concentration (8 mg/L) without lactoferrin

Sponsors & Collaborators

• University of California

  collaborator OTHER

• Mead Johnson Nutrition

  collaborator INDUSTRY

• Umeå University

  lead OTHER

Principal Investigators

• Staffan K Berglund, MD, PhD · Umeå University

• Olle Hernell, Professor · Umeå University

• Bo Lönnerdal, Professor · University of California

• Carolyn Slupsky, PhD · University of California

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Weeks

Max Age

8 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2019-05-31

Completion

2024-05-31

Countries

• Sweden

Study Locations