Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.
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|ClinicalTrials.gov Identifier: NCT03385590|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2017
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Soy-fiber-maize Dietary Supplement: Maize||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|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.|
|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|
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.
- 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.
- 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.
- Number of bowel movements [ Time Frame: Weekly - baseline through 6 months ]Number of bowel movements per week
- Microbiota profile changes [ Time Frame: Baseline, month 3 and month 6 ]Percent change at phylum and genus levels; changes in OTUs
- Growth [ Time Frame: Baseline, month 3 and month 6 ]Increase in height, weight and Mid Upper Arm Circumference
- Dietary intake [ Time Frame: Baseline, month 3 and month 6 ]24-hour dietary recall assessing intake of children
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
|Kabudula Community Hospital|
|Principal Investigator:||Wendy Dahl, PhD||University of Florida|