Assessment of Complementary Feeding of Canadian Infants (Infant Feeding)

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

Study Overview

• Status: Completed
• Conditions: Intestinal Inflammation; Generation of Reactive Oxygen Species
• Intervention / Treatment: Other: Iron fortified cereal; Other: Iron fortified cereal with fruit; Other: Meat

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T6C5
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Consumption of more than 200ml formula

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: A; Iron fortified cereal	Other: Iron fortified cereal; Infants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat); Other Names: Infant feeding
OTHER: B; Iron fortified cereal with fruit	Other: Iron fortified cereal with fruit
OTHER: C; Meat	Other: Meat

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 8OH-deoxyguanosine	Oxidative stress marker in the urine	Before introduction of study food and 2-3 weeks after introduction of study food
Change in F2 Isoprostane	Oxidative stress marker in the urine	Before introduction of study food and 2-3 weeks after introduction of study food

Collaborators and Investigators

• Sponsor: University of Manitoba

Publications and helpful links

General Publications

• Qasem W, Azad MB, Hossain Z, Azad E, Jorgensen S, Castillo San Juan S, Cai C, Khafipour E, Beta T, Roberts LJ 2nd, Friel J. Assessment of complementary feeding of Canadian infants: effects on microbiome & oxidative stress, a randomized controlled trial. BMC Pediatr. 2017 Feb 14;17(1):54. doi: 10.1186/s12887-017-0805-0.

Helpful Links

• Study Information

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (ESTIMATE): February 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Iron; Intestinal inflammation; ROS
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: H2011:166