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

Nestlé

Status

Completed

Conditions

Iron Absorption

Treatments

Other: Test formula B with synbiotic

Other: Test formula C with HMOs

Other: Test formula A without added pre- and pro-biotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT04774016

18.15.INF

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

40 to 56 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Written informed consent has been obtained from the parents/legally acceptable representative
Child aged 40-56 weeks (± 3 weeks)
Child exhibits no clinical signs/symptoms of chronic disease or acute illness
Capillary Hb ≥70 g/L
Anticipated residence in the area for the study duration
Z-scores for weight-for-age and weight-for-length both >-3, if the infant is severely underweight or severely malnourished.
Singleton, full-term gestation birth (≥37 weeks)
Birth weight ≥2.5 kg and ≤4.5 kg

Exclusion criteria

Child exhibits clinical signs/symptoms of chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth
Child received vitamin and mineral supplements in the 2 weeks prior to enrollment
Child is exclusively breastfed
Child received antibiotic treatments in the 4 weeks prior to enrollment
Parents or caretakers not willing/not able to comply with the requirements of the study protocol
Child has allergy or intolerance to cows' milk protein or lactose, or severe food allergies
Child is participating in any other interventional clinical trial that would interfere with study outcomes