Assessment of Complementary Feeding of Canadian Infants

NCT01790542 | Completed

• 1 other identifier: H2011:166
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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. 1.Consumption of infant cereals with iron will increase ROS generation in the gut
2. 2.Consumption of infant cereals with iron and fruit will decrease ROS in the gut
3. 3.Consumption of meat will not generate ROS
4. 4.Consumption of iron fortified cereals or meat will maintain iron status during infancy

Conditions

Generation of Reactive Oxygen Species; Intestinal Inflammation

Keywords

Iron; Intestinal inflammation; ROS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Microbiome

  Before introduction of study food and 2-3 weeks after introduction of study food

• Change in Fecal Calprotectin

  Before introduction of study food and 2-3 weeks after introduction of study food

• Fecal non heme iron production

  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 Outcomes (2)

• Change in 8OH-deoxyguanosine

  Before introduction of study food and 2-3 weeks after introduction of study food

• Change in F2 Isoprostane

  Before introduction of study food and 2-3 weeks after introduction of study food

Study Arms (3)

A

OTHER

Iron fortified cereal

Other: Iron fortified cereal

B

OTHER

Iron fortified cereal with fruit

Other: Iron fortified cereal with fruit

C

OTHER

Meat

Other: Meat

Interventions

Iron fortified cereal OTHER

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

Also known as: Infant feeding

A

Iron fortified cereal with fruit OTHER

B

Meat OTHER

C

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Consumption of more than 200ml formula

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T6C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 28196533 DERIVED

Related Links

• Study Information

MeSH Terms

Interventions

Fruit; Meat

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 13, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 28, 2015

Record last verified: 2014-07

Locations

CA (1)