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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Compliance to feeding protocol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Compliance to feeding protocol
时间窗: 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.
次要结局
- Microbiota profile changes(Baseline, month 3 and month 6)
- Dietary intake(Baseline, month 3 and month 6)
- Growth(Baseline, month 3 and month 6)
- Stool consistency(Weekly - baseline through 6 months)
- Number of bowel movements(Weekly - baseline through 6 months)