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Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03385590
Study type Interventional
Source University of Florida
Status Active, not recruiting
Phase N/A
Start date June 21, 2018
Completion date August 31, 2019

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