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

University of Florida158 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

158

Conditions

Healthy

Interventions

Soy-fiber-maizeDIETARY_SUPPLEMENT

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.

MaizeDIETARY_SUPPLEMENT

Two servings of maize porridge will be consumed by the children each day for a period of six months.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kabudula Community Hospital

Lilongwe, Malawi

Outcomes

Primary Outcomes

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.

Time frame: Weekly - baseline through 6 months

Secondary Outcomes

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.

Time frame: Weekly - baseline through 6 months

Number of bowel movements

Number of bowel movements per week

Time frame: Weekly - baseline through 6 months

Microbiota profile changes

Percent change at phylum and genus levels; changes in OTUs

Time frame: Baseline, month 3 and month 6

Growth

Increase in height, weight and Mid Upper Arm Circumference

Time frame: Baseline, month 3 and month 6

Dietary intake

24-hour dietary recall assessing intake of children

Time frame: Baseline, month 3 and month 6

Data from ClinicalTrials.gov

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