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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Soy-fiber-maize; Dietary supplement: Maize

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Kabudula Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soy-fiber-maize; Complementary food composed of soybean, soy fiber and maize flours.	Dietary supplement: Soy-fiber-maize; 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.
Active Comparator: Maize; Complementary food composed of maize flour.	Dietary supplement: Maize; Two servings of maize porridge will be consumed by the children each day for a period of six months.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Michigan State University
• Investigators: Principal Investigator: Wendy Dahl, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: healthy
• Other Study ID Numbers: IRB201700644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No