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Assessment of Complementary Feeding of Canadian Infants

Assessment of Complementary Feeding of Canadian Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01790542
Acronym
Infant Feeding
Enrollment
87
Registered
2013-02-13
Start date
2012-12-31
Completion date
2014-09-30
Last updated
2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generation of Reactive Oxygen Species, Intestinal Inflammation

Keywords

Iron, Intestinal inflammation, ROS

Brief summary

With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6 months of age there has arisen concern about what is the best solid food to introduce at that time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified rice cereal was the first food of choice. New recommendations from Health Canada include meat as a potential first food as well as other iron fortified foods. This has lead to uncertainty of both public health officials and parents about the optimal introduction and choice of solids after exclusive breastfeeding. In addition to meeting iron needs with the first solid food choice, the investigators are concerned about the possible generation of reactive oxygen species (ROS) in the gut of the infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that most of the residual iron enters the colon. Normally excess iron is sequestered by a variety of mechanisms in the body, but there is no such system for the sequestering of iron in the gut lumen. The investigators have shown that providing iron supplements to adults where the majority of the iron is unabsorbed passes through the digestive tract can lead to the generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will receive the same dose and are likely producing ROS in their digestive tract. This may cause inflammation and make infants more susceptible to disease. The investigators think that meats and infant cereals with phenolic antioxidants available from fruits will likely reduce the generation of ROS in vivo. Therefore the investigators wish to determine if traditional and newly recommended first foods are safe from a free radical and inflammatory perspective. HYPOTHESES: 1. Consumption of infant cereals with iron will increase ROS generation in the gut 2. Consumption of infant cereals with iron and fruit will decrease ROS in the gut 3. Consumption of meat will not generate ROS 4. Consumption of iron fortified cereals or meat will maintain iron status during infancy

Interventions

Infants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat)

OTHERIron fortified cereal with fruit
OTHERMeat

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes

Inclusion criteria

* Full term infant * Birth weight more than 2500g * Absence of any medical conditions

Exclusion criteria

* Consumption of more than 200ml formula

Design outcomes

Primary

MeasureTime frameDescription
Change in production of ROSBefore introduction of study food and 2-3 weeks after introduction of study foodProduction of reactive oxygen species

Secondary

MeasureTime frameDescription
Change in MicrobiomeBefore introduction of study food and 2-3 weeks after introduction of study foodMicroflora of term infants before and after the introduction of solids
Change in Fecal CalprotectinBefore introduction of study food and 2-3 weeks after introduction of study foodInflammatory marker
Fecal non heme iron productionBefore introduction of study food and 2-3 weeks after introduction of study foodNon heme iron founded in infant cereal is less absorbed, remains in the gut, and excreted in the feces.
Dietary iron intake from first complementary food3 days dietary record
Micro and Macro nutrient intake of breastfed infants from first complementary food3 days dietary record

Other

MeasureTime frameDescription
Change in 8OH-deoxyguanosineBefore introduction of study food and 2-3 weeks after introduction of study foodOxidative stress marker in the urine
Change in F2 IsoprostaneBefore introduction of study food and 2-3 weeks after introduction of study foodOxidative stress marker in the urine

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026