Acceptability of a Cereal for Complementary Feeding of Infants and Young Children Made From Caterpillars (CAT01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01258647|
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : August 30, 2011
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Stunting of Growth||Dietary Supplement: caterpillar cereal||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Caterpillar Cereal: Maternal and Infant Acceptability|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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.
- Maternal acceptability [ Time Frame: Maternal acceptability will be measured on the first day of the trial. ]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. ]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. ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258647
|Kinshasa School of Public Health|
|Kinshasa, Congo, B.P. 11850|
|Principal Investigator:||Carl L Bose, MD||University of North Carolina|