Healthy
Conditions
Keywords
healthy
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.
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.
Interventions
DIETARY_SUPPLEMENTSoy-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.
DIETARY_SUPPLEMENTMaize
Two servings of maize porridge will be consumed by the children each day for a period of six months.
Sponsors
Michigan State University
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, 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.
Intervention model description
Children 6-36 months will be fed soy-fiber-maize or soy-maize complementary foods for 6 months.
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance to feeding protocol | 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
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency | 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 | Weekly - baseline through 6 months | Number of bowel movements per week |
| Microbiota profile changes | Baseline, month 3 and month 6 | Percent change at phylum and genus levels; changes in OTUs |
| Growth | Baseline, month 3 and month 6 | Increase in height, weight and Mid Upper Arm Circumference |
| Dietary intake | Baseline, month 3 and month 6 | 24-hour dietary recall assessing intake of children |
Countries
Malawi
Outcome results
None listed