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

August 26, 2011 updated by: Carl Bose, University of North Carolina, Chapel Hill

Caterpillar Cereal: Maternal and Infant Acceptability

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In preparation for a controlled study of the efficacy of daily intake of caterpillar cereal versus the usual diet from 6 to 18 months of age in reducing the rate of stunting of linear growth, and the improvement in other health outcomes, we will conduct an acceptability trial. In this trial, we will test the mothers' acceptance of the caterpillar cereal and their willingness to feed their young children this product. We will also test the infants' acceptance and their capacity to consume quantities required in the controlled trial necessary to deliver the desired quantities of micronutrients.

Study Design

A cohort of 20 mother-infant dyads will be recruited. The site of recruitment will be the area Health Center. Infants will be between 8 and 10 months of age and will have no major health problems. Infants with minor, inter-current illnesses at the time of recruitment that might interfere with oral intake will be excluded. After informed consent, maternal and infant acceptability will be tested using the methods described below.

Maternal Acceptability

Mothers will be provided with a 30 g portion of caterpillar cereal and will be instructed in the proper technique for preparation. After preparation, mothers will be asked to evaluate five features of the cereal. They will also be asked to provide their overall impression of the cereal. In each category, the evaluation will be assigned a numerical score using a five-part Likert scale, from "like very much" to "dislike very much".

The evaluation will be conducted by the Community Coordinator (CC) who will provide instruction about cereal preparation and administer the evaluative tool. Each evaluation will be conducted confidentially. Mothers will not be aware of the response of other mothers. At the conclusion of a one-week period of feeding (see below), a questionnaire will be administered to assess mothers' attitudes about their willingness to participate in a one-year study of cereal feeding.

We do not intend to evaluate their attitudes about food preparation. The recommended preparation technique of the caterpillar cereal is very similar to preparation of enriched soy cereal in our ongoing complementary feeding study. This involves boiling water and cooking the cereal for approximately three minutes. Although this preparation technique is burdensome, it has not compromised compliance in the ongoing study. Therefore, we would expect a similar response from mothers in the proposed study.

Infant Acceptability

Following the evaluation of maternal acceptability, each mother will be provided with a one-week supply of caterpillar cereal (7 individual packets containing 30 g each). She will be instructed to begin daily feedings on the following day, and to continue until the cereal packets have all been used. The first feeding will occur during a home visit by the CC, who will repeat the preparation instructions, and will observe the first feeding. The CC will return to the home on alternate days throughout the week to reinforce instructions regarding preparation, and to make observations about infant feeding habits. Although frequent visits may influence the likelihood of maternal compliance and hence may mislead investigators about maternal acceptability, it will not effect infant acceptability.

Mothers will be instructed not to feed the cereal to other household members, and will be asked to return uneaten cereal to the original packet for collection by the CC at the end of the week.

On the 8th day, the day following the completion of use of the cereal, the CC will return to the home for the purpose of data collection. The CC will administer a 24-hour dietary recall, and collect all cereal packets. In addition, mothers will be asked questions about the infant's health status.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Congo
      • Kinshasa, Congo, B.P. 11850
        • Kinshasa School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months to 10 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Maternal acceptability will be measured on the first day of the trial.
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 acceptability will be measured during the one week study period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
This outcome will be measured throughout the one week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Davis
Bill and Melinda Gates Foundation
Kinshasa School of Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carl L Bose, MD, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-0509

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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