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

NCT ID: NCT03385590

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Healthy

Keywords

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healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Subjects will be blinded, on-site investigator will not be blinded due to the difficulty with blinding the foods. The off-site PI and outcome assessors will be blinded.

Study Groups

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Soy-fiber-maize

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

Group Type EXPERIMENTAL

Soy-fiber-maize

Intervention Type DIETARY_SUPPLEMENT

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

Complementary food composed of maize flour.

Group Type ACTIVE_COMPARATOR

Maize

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Maize

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michigan State University

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy Dahl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Kabudula Community Hospital

Lilongwe, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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IRB201700644

Identifier Type: -

Identifier Source: org_study_id