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Completed

NCT Number: NCT03385590

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

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.

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Key information

Conditions

Healthy

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kabudula Community Hospital

Lilongwe, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soy-fiber-maize

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

Dietary Supplement

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

Primary outcomes

  1. Compliance to feeding protocol

    Time frame: Weekly - baseline through 6 months

    Acceptability and feasibility of soy-fiber-maize blend versus maize only complementary food as measured by compliance to feeding complementary food.

Secondary outcomes

  1. Stool consistency

    Time frame: Weekly - baseline through 6 months

    Stool consistency rating by Modified Bristol Stool Form Scale for Children, scale of 1-5, = with fewer 4 and 5 scores considered improvment.

  2. Number of bowel movements

    Time frame: Weekly - baseline through 6 months

    Number of bowel movements per week

  3. Microbiota profile changes

    Time frame: Baseline, month 3 and month 6

    Percent change at phylum and genus levels; changes in OTUs

  4. Growth

    Time frame: Baseline, month 3 and month 6

    Increase in height, weight and Mid Upper Arm Circumference

  5. Dietary intake

    Time frame: Baseline, month 3 and month 6

    24-hour dietary recall assessing intake of children

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Michigan State University

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 28, 2017
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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