Acceptability of a Cereal for Complementary Feeding of Infants and Young Children Made From Caterpillars

NCT01258647 | Completed

• 1 other identifier: 10-0509
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micronutrients. Although supplementation with selected micronutrients may avoid certain deficiency states, CF with animal source foods may be necessary to avoid stunting. Meat is not readily available in many Central African countries. However caterpillars, which are locally available and abundant, are a common staple in adult diets and may be a suitable substitute for animal source proteins in CF. The investigators developed a cereal made from dried caterpillars that has a nutrient content that appears to be ideal for CF. Maternal and infant acceptability will be evaluated in 20 mothers and their 8 month old infants. The investigators hypothesize that this cereal will be accepted by both mothers and infants: acceptability will be based on a priori definitions.

Conditions

Malnutrition; Stunting of Growth

Keywords

infant nutrition; complementary feeding; malnutrition; stunting of growth

Outcome Measures

Primary Outcomes (2)

• Maternal acceptability

  Maternal acceptability will be defined as a median score for each of 5 features (smell, taste, texture, color, consistency, overall impression) of 3 or greater on a 5 point Likert scale.

  Maternal acceptability will be measured on the first day of the trial.

• Infant acceptability

  Each mother will be provided with a one-week supply of caterpillar cereal and will be instructed to begin daily feedings for a period of one week. Infant acceptability will be defined as the consumption of greater than 75% of the total cereal allotment by all infants during the last four days of feeding.

  Infant acceptability will be measured during the one week study period.

Secondary Outcomes (1)

• Infant tolerance

  This outcome will be measured throughout the one week intervention.

Study Arms (1)

Feeding group

EXPERIMENTAL

The feeding group will include 20 mother/infant dyads. The infants will be between 8 and 10 months of age.

Dietary Supplement: caterpillar cereal

Interventions

caterpillar cereal DIETARY_SUPPLEMENT

A 30 gram portion of a cereal containing one part dried, ground caterpillar, one part corn flour and small quantities of sugar and palm oil will be evaluated by the mothers and then fed daily for seven days to infants.

Feeding group

Eligibility Criteria

• Age: 8 Months - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any mother-infant dyad living within each a study community in the Equateur Province. Infants must be 8-10 months of age at the time of recruitment.

You may not qualify if:

• Infants with minor inter-current illness that may interfere with oral intake
• Infants of multiple gestation births
• Infants with congenital anomalies
• Infants likely to receive free or subsidized complementary foods (or infant formula)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Kinshasa School of Public Health: collaborator
• University of California, Davis: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Kinshasa School of Public Health

Kinshasa, B.P. 11850, Republic of the Congo

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Carl L Bose, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 13, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

RE (1)