Acceptability of a Cereal for Complementary Feeding of Infants and Young Children Made From Caterpillars (CAT01)
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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 |
- 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.
- 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 |
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| Congo | |
| Kinshasa School of Public Health | |
| Kinshasa, Congo, B.P. 11850 | |
| 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 May 16, 2013