Clinical trial NCT03385590: Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2017-12-28
Enrollment: 158
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
Primary purpose: OTHER

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, gastrointestinal symptoms, microbiota composition and activity.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance to feeding protocol
timeFrame: Weekly - baseline through 6 months
Secondary outcomes:
measure: Stool consistency
timeFrame: Weekly - baseline through 6 months
measure: Number of bowel movements
timeFrame: Weekly - baseline through 6 months
measure: Microbiota profile changes
timeFrame: Baseline, month 3 and month 6
measure: Growth
timeFrame: Baseline, month 3 and month 6
measure: Dietary intake
timeFrame: Baseline, month 3 and month 6
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Kabudula Community Hospital
Study officials:
affiliation: University of Florida
name: Wendy Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: