NCT04774016

Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides

Iron Absorption From an Iron-fortified Follow-up Formula With and Without the Addition of a Synbiotic or Human Milk Oligosaccharides: a Stable Isotope Study in 10-14 Month-old Thai Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 40 Weeks – 56 Weeks
• Healthy volunteers: Accepted

Summary

The co-primary objectives of this study are: 1) to investigate the effect adding a synbiotic (combination of a pre-and probiotic) to iron-fortified follow-up formula (FUF) on iron bioavailability, and 2) to investigate the effect adding Human Milk Oligosaccharides (HMOs) to iron-fortified FUF on iron bioavailability in 10-14 month-old Thai children.

Detailed description

Iron stores of healthy, full-term neonates are supposed to cover iron needs for the first 4-6 months of life. After 6 months of age, requirements for absorbed iron are high, as infants need to build body iron stores and triple their body weight before the first year of life. Iron concentrations in mature breastmilk are low (\~0.3 mg/L) and cannot adequately cover the high iron requirements of children between 6 and 24 months of age. Follow-up formulas (FUF) are fortified milk-based products intended for infants above 6 months of age and young children aged 1-3 years, and are widely used as a liquid part of the weaning diet to supplement the diet of young children with macro- and micronutrients. Prebiotics and probiotics are increasingly added to foods for infants and young children due to emerging evidence on possible health benefits. We recently showed that the addition of prebiotic galacto-oligosaccharides (GOS) to an iron-containing micronutrient powder increased iron absorption in Kenyan infants. To our knowledge, the effect of the combination of pre- and probiotics (synbiotic) or human milk oligosaccharides (HMOs) on iron absorption from an iron-fortified FUF has not been investigated. Thai children (10-14 months old) will be assigned to receive FUF fortified with isotopically labelled iron as FeSO4 1) with synbiotic, 2) HMO, and 3) without added prebiotics as a reference, in random order. Besides the iron source and synbiotic or HMO, the test FUF will be identical in terms of macro- and micronutrient composition. For the secondary objectives of this study, which will have a single-group, before-after design, each infant will receive the test FUF with added synbiotic for 25 days on gut comfort and quality of life outcomes.

Conditions

• Iron Absorption

Interventions

Type	Name	Description
OTHER	Test formula A without added pre- and pro-biotic	An identical formula as test formulas fortified with 2.20 mg iron as FeSO4-58 and 0.05 mg native iron per serving (235 ml), but without added pre- or probiotic.
OTHER	Test formula B with synbiotic	Test formula fortified with 2.20 mg iron as FeSO4-57 and 0.05 mg native iron per serving (235 ml) and added synbiotic.
OTHER	Test formula C with HMOs	Test formula fortified with 2.20 mg iron as FeSO4-54 and 0.05 mg native iron per serving (235 ml) and added HMOs.

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-03-23
• Completion: 2021-06-07
• First posted: 2021-02-26
• Last updated: 2023-03-24

Locations

1 site across 1 country: Thailand