Assessment of Complementary Feeding of Canadian Infants

Study Overview
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Brief Summary
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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: Consumption of infant cereals with iron will increase ROS generation in the gut Consumption of infant cereals with iron and fruit will decrease ROS in the gut Consumption of meat will not generate ROS Consumption of iron fortified cereals or meat will maintain iron status during infancy

Official Title
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Assessment of Complementary Feeding of Canadian Infants

Conditions
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Generation of Reactive Oxygen Species, Intestinal Inflammation

Intervention / Treatment
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* Other: Iron fortified cereal
* Other: Iron fortified cereal with fruit
* Other: Meat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term infant Birth weight more than 2500g Absence of any medical conditions Exclusion Criteria: Consumption of more than 200ml formula

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Iron fortified cereal | Other: Iron fortified cereal<br>* Infants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat)<br>* Other names: Infant feeding;|
| Other: B<br>Iron fortified cereal with fruit | Other: Iron fortified cereal with fruit<br> <br> |
| Other: C<br>Meat | Other: Meat<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in production of ROS | Production of reactive oxygen species | Before introduction of study food and 2-3 weeks after introduction of study food | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Microbiome | Microflora of term infants before and after the introduction of solids | Before introduction of study food and 2-3 weeks after introduction of study food | 
| Change in Fecal Calprotectin | Inflammatory marker | Before introduction of study food and 2-3 weeks after introduction of study food | 
| Fecal non heme iron production | Non heme iron founded in infant cereal is less absorbed, remains in the gut, and excreted in the feces. | Before introduction of study food and 2-3 weeks after introduction of study food | 
| Dietary iron intake from first complementary food |  | 3 days dietary record | 
| Micro and Macro nutrient intake of breastfed infants from first complementary food |  | 3 days dietary record | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROS, Iron, Intestinal inflammation