Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.

Study Overview
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Brief Summary
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The purpose of this intervention study is to assess the feasibility and acceptability of soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit time, growth, gastrointestinal symptoms, microbiota composition and activity.

Detailed Description
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This is a 6-month randomized study to assess the feasibility and acceptability of soy-fiber-maize complementary food. Participants (caregiver/mother - child pairs) will complete a 2-week baseline period during which stool frequency, and stool consistency will be collected by paper questionnaire, and participants will collect a single stool. Dietary data will be obtained at baseline, 3 months and at 6 months during the study period. Participants will receive soy-fiber-maize or maize complementary foods twice a day for 6 months. Participants will attend a study visit every week for study food collection. During the study visit at baseline, 3 and 6 months, participants will complete a 24-hour dietary recall and height, weight and Mid Upper Arm Circumference will be measured on the children. At these same times, participants will provide stool samples. Participants will complete weekly questionnaires to assess gastrointestinal health, stool frequency and stool form. Furthermore, participants will participate in a focus group discussion at the end of the 6 months' study period to assess the feasibility and acceptability of soy-fiber-maize complementary foods for their children. Stool samples will be analyzed for differences in the microbiota.

Official Title
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The Feasibility and Acceptability of a Soy-fiber-maize Blend Complementary Food and Its Effects on Stool Frequency, Stool Consistency, Microbiota Composition, Growth, and Dietary Intake of Children Aged 6 to 36 Months in Malawi.

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Soy-fiber-maize
* Dietary Supplement: Maize


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to have height and weight measured and provide demographic information (e.g age, race, sex). Willing to consume soy fiber or control porridge twice daily for a 6 months' period Willing to complete a weekly questionnaire throughout the entire 6 months' study. Willing to be interviewed for 24-Hour recall 3 times per 6 months' period throughout the study. Willing to provide 3 stool samples, one in each 2-weeks period throughout the study. Exclusion Criteria: Have any known food allergies. Are currently taking medications for diarrhea. Have taken antibiotics within the past four weeks prior to randomization. Have more than 3 diarrheal episodes in the last week Currently participating in a clinical trial.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soy-fiber-maize<br>Complementary food composed of soybean, soy fiber and maize flours. | Dietary Supplement: Soy-fiber-maize<br>* Two servings of soy-maize porridge fortified with soy fiber (1.3 g per serving) will be consumed by the children each day for a period of six months.<br>|
| Active Comparator: Maize<br>Complementary food composed of maize flour. | Dietary Supplement: Maize<br>* Two servings of maize porridge will be consumed by the children each day for a period of six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to feeding protocol | Acceptability and feasibility of soy-fiber-maize blend versus maize only complementary food as measured by compliance to feeding complementary food. | Weekly - baseline through 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency | Stool consistency rating by Modified Bristol Stool Form Scale for Children, scale of 1-5, = with fewer 4 and 5 scores considered improvment. | Weekly - baseline through 6 months | 
| Number of bowel movements | Number of bowel movements per week | Weekly - baseline through 6 months | 
| Microbiota profile changes | Percent change at phylum and genus levels; changes in OTUs | Baseline, month 3 and month 6 | 
| Growth | Increase in height, weight and Mid Upper Arm Circumference | Baseline, month 3 and month 6 | 
| Dietary intake | 24-hour dietary recall assessing intake of children | Baseline, month 3 and month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy