Status:
COMPLETED
Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Michigan State University
Conditions:
Healthy
Eligibility:
All Genders
6-36 years
Phase:
NA
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, gastroi...
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 peri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03385590
Start Date
June 21 2018
End Date
November 30 2019
Last Update
December 12 2019
Active Locations (1)
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1
Kabudula Community Hospital
Lilongwe, Malawi