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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Soy-fiber-maize; Dietary Supplement: Maize

• Registration Number: NCT03385590
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Study Start: 2018-06-21
• Primary Completion: 2018-12-31
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soy-fiber-maize	Soy-fiber-maize	Complementary food composed of soybean, soy fiber and maize flours.
Maize	Maize	Complementary food composed of maize flour.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kabudula Community Hospital; 🇲🇼 Lilongwe, Malawi