Acceptability of a Cereal for Complementary Feeding of Infants and Young Children Made From Caterpillars (CAT01)

This study has been completed.
Sponsor:
Collaborators:
Kinshasa School of Public Health
University of California, Davis
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Carl Bose, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01258647
First received: December 9, 2010
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Malnutrition
Stunting of Growth
Dietary Supplement: caterpillar cereal

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Caterpillar Cereal: Maternal and Infant Acceptability

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Maternal acceptability [ Time Frame: Maternal acceptability will be measured on the first day of the trial. ] [ Designated as safety issue: No ]
    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.

  • Infant acceptability [ Time Frame: Infant acceptability will be measured during the one week study period. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Infant tolerance [ Time Frame: This outcome will be measured throughout the one week intervention. ] [ Designated as safety issue: Yes ]

    During the visits by the Community Coordinator, mothers will be asked question about the infant's health status and specifically about any signs or symptoms attributable to feeding.

    Tolerance will be defined as the absence of signs or symptoms attributable to cereal consumption (diarrhea or emesis unless other family members have developed these symptoms during the week of feeding).



Enrollment: 40
Study Start Date: October 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Feeding group
The feeding group will include 20 mother/infant dyads. The infants will be between 8 and 10 months of age.
Dietary Supplement: caterpillar cereal
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Months to 10 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01258647

Locations
Congo
Kinshasa School of Public Health
Kinshasa, Congo, B.P. 11850
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Kinshasa School of Public Health
University of California, Davis
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Carl L Bose, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Carl Bose, Prinicipal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01258647     History of Changes
Other Study ID Numbers: 10-0509
Study First Received: December 9, 2010
Last Updated: August 26, 2011
Health Authority: Democratic Republic of Congo: Ministry of Public Health

Keywords provided by University of North Carolina, Chapel Hill:
infant nutrition
complementary feeding
malnutrition
stunting of growth

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 18, 2014