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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385590
• Other study ID #: IRB201700644
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Malawi	Kabudula Community Hospital	Lilongwe

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Michigan State University

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weekly - baseline through 6 months
Secondary	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.	Weekly - baseline through 6 months
Secondary	Number of bowel movements	Number of bowel movements per week	Weekly - baseline through 6 months
Secondary	Microbiota profile changes	Percent change at phylum and genus levels; changes in OTUs	Baseline, month 3 and month 6
Secondary	Growth	Increase in height, weight and Mid Upper Arm Circumference	Baseline, month 3 and month 6
Secondary	Dietary intake	24-hour dietary recall assessing intake of children	Baseline, month 3 and month 6