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

University of Florida

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Maize; Dietary Supplement: Soy-fiber-maize

Study type: Interventional

Funder types: Other

Identifiers

NCT03385590

IRB201700644

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups

Soy-fiber-maize

Experimental group

Description:

Complementary food composed of soybean, soy fiber and maize flours.

Treatment:

Dietary Supplement: Soy-fiber-maize

Maize

Active Comparator group

Description:

Complementary food composed of maize flour.

Treatment:

Dietary Supplement: Maize