Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Health of Formula-fed Children
- Sponsor
- Umeå University
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- Incidence of infections
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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).
Investigators
Staffan Berglund
MD, PhD
Umeå University
Eligibility Criteria
Inclusion Criteria
- •Formula-fed healthy infants at 6 +/- 2 weeks of age with:
- •birth weight 2500-4500 g
- •gestational age at birth ≥ 37 completed weeks
- •no chronic disease or neonatal diagnoses believed to affect any outcome
- •no given blood transfusions or iron supplements
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of infections
Time Frame: Up to 12 months of age
Morbidity journal, Health questionnaire
Cytokine levels
Time Frame: At 6 months of age
IL-2, TNF-alpha
Iron status
Time Frame: At 6 months of age
s-ferritin, s-transferrin, s-iron, s-transferrin receptor concentration, reticulocyte Hb
Secondary Outcomes
- Antibody response to vaccines(At baseline, 4, 6 and 12 months of age)
- Dietary intake(At baseline, 3, 4, 5, 6 and 12 months of age)
- Growth(At baseline, 4, 6, 12 months of age and 6 years of age)
- Bloodpressure(At baseline, 4, 6, 12 months of age and 6 years of age)
- Gut microbiota(At baseline, 4, 6, 12 months of age and 6 years of age)
- Saliva proteins(At 4 months of age)
- Inflammatory markers(At baseline, 4, 6 and 12 months of age and 6 years age)
- Cognitive development and behavior(At 1 and 6 years of age)
- s-hepcidin(At baseline, 4, 6, 12 months of age and 6 years of age)
- Metabolomics(At baseline, 4, 6, 12 months of age and 6 years of age)
- Amino acids(At 4 and 6 months of age)
- Blood urea nitrogen(At 4 and 6 months of age)
- Iron status(At baseline, 4 and 12 months of age and 6 years of age)
- Cytokine levels(At baseline, 4, 6, 12 months of age and 6 years of age)