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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03385590
Recruitment Status : Active, not recruiting
First Posted : December 28, 2017
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Soy-fiber-maize Dietary Supplement: Maize Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
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.
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Soy-fiber-maize
Complementary food composed of soybean, soy fiber and maize flours.
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.

Active Comparator: Maize
Complementary food composed of maize flour.
Dietary Supplement: Maize
Two servings of maize porridge will be consumed by the children each day for a period of six months.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385590


Locations
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Malawi
Kabudula Community Hospital
Lilongwe, Malawi
Sponsors and Collaborators
University of Florida
Michigan State University
Investigators
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Principal Investigator: Wendy Dahl, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03385590     History of Changes
Other Study ID Numbers: IRB201700644
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
healthy