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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2018

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.

Interventions

  • 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.
  • Dietary Supplement: Maize
    • Two servings of maize porridge will be consumed by the children each day for a period of six months.

Arms, Groups and Cohorts

  • Experimental: Soy-fiber-maize
    • Complementary food composed of soybean, soy fiber and maize flours.
  • Active Comparator: Maize
    • Complementary food composed of maize flour.

Clinical Trial Outcome Measures

Primary Measures

  • Compliance to feeding protocol
    • Time Frame: 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 Measures

  • Stool consistency
    • Time Frame: 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
    • Time Frame: Weekly – baseline through 6 months
    • Number of bowel movements per week
  • Microbiota profile changes
    • Time Frame: Baseline, month 3 and month 6
    • Percent change at phylum and genus levels; changes in OTUs
  • Growth
    • Time Frame: Baseline, month 3 and month 6
    • Increase in height, weight and Mid Upper Arm Circumference
  • Dietary intake
    • Time Frame: Baseline, month 3 and month 6
    • 24-hour dietary recall assessing intake of children

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 36 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • Michigan State University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wendy Dahl, PhD, Principal Investigator, University of Florida

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