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| Name | Class |
|---|---|
| Michigan State University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy-fiber-maize | Experimental | Complementary food composed of soybean, soy fiber and maize flours. |
|
| Maize | Active Comparator | Complementary food composed of maize flour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of bowel movements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Dahl, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kabudula Community Hospital | Lilongwe | Malawi |
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Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
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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.
| Maize | Dietary Supplement | Two servings of maize porridge will be consumed by the children each day for a period of six months. |
|
Number of bowel movements per week
| Weekly - baseline through 6 months |
| Microbiota profile changes | Percent change at phylum and genus levels; changes in OTUs | Baseline, month 3 and month 6 |
| Growth | Increase in height, weight and Mid Upper Arm Circumference | Baseline, month 3 and month 6 |
| Dietary intake | 24-hour dietary recall assessing intake of children | Baseline, month 3 and month 6 |