The Addition of Whole Grains to the Diets of Middle-school Children: A Study of Digestive Health and Immune Defenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Stool frequency
研究概览
简要总结
The Dietary Guidelines for Americans recommend that children and adolescents "consume whole-grain products often; at least half the grains should be whole grains." Few, if any studies, examine the benefit of whole grains on the health of adolescents. The purpose of this study is to determine if adolescents eating diets rich in whole grains vs. diets rich in refined grains (i.e., a typical diet) have improved markers of digestive and immune health.
详细描述
Middle-school students will be recruited and randomized to receive >/=80 g of whole grains (>/=5 servings) or similar foods made with refined grains each day for six weeks. Based on treatment group, subjects will be provided either whole grain or refined grain foods and snacks. They will be instructed on how to use these foods to replace other foods already contained in the diet. Stool, blood, and saliva samples will be obtained at baseline and at study end to examine the microbiota and markers of digestive and immune health. Daily records will be maintained by the students to assess bowel habits and compliance. It is anticipated that whole grains will increase stool bulk resulting in increased stool frequency and softer stools. Additionally, fermentation of the fiber within the colon will alter the microbiota profile. Because the majority of the immune system resides within the gastrointestinal tract, improved balance of the intestinal microbiota may prime the immune system thus contributing to improved immune defense.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Middle-school student at Westwood Middle School, Gainesville, FL
- •Parental/guardian consent
- •Willing to eat three different study foods each day for six weeks
- •Willing to provide two blood samples and two saliva samples over the course of the study
排除标准
- •Taking medications for constipation or diarrhea
- •Antibiotic therapy within the past four weeks prior to randomization
- •Takes probiotics or consumes greater than three servings of yogurt per week
- •Has any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-modulating diseases (HIV, AIDS, autoimmune, hepatitis, cancer, etc.)
- •Has any food allergies (wheat, soy, egg, milk, gluten, nuts, or any other food or food ingredient)
结局指标
主要结局
Stool frequency
时间窗: 6 weeks
次要结局
- Changes in overall microbiota diversity(6 weeks)
- Inflammatory markers(6 weeks)
- Secretory IgA(6 weeks)