Promoting Gastrointestinal Health and Reducing Subclinical Inflammation in Obese Individuals Through Intake of Whole Wheat Products in Comparison With Fruits and Vegetables
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
研究概览
简要总结
This study evaluates the impact of increased intake of fruits and vegetables and whole grains on markers of inflammation and gut microbial composition. The treatment groups are 3 servings of whole grain per day; 5 servings of fruits and vegetables per day; and a control (3 servings of refined grains per day provided).
详细描述
Literature data suggests that fruits and vegetables and whole grains containing dietary fiber and other nutrients are important for maintaining beneficial microbes in the gut. The presence of beneficial microbes in the gut may mediate the subclinical inflammation experienced in metabolic disease. In this project, overweight or obese participants with low intakes of fruits and vegetables or whole grains will increase their intake of these foods to recommended levels. Changes in markers of inflammation and gut microbiota composition will be determined to assess and compare the potential impact of these foods on metabolic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese or overweight men or women (body mass index, BMI, ≥25 kg/m2)
- •Free of known gastrointestinal disease
- •No supplements use (excluding multivitamin)
- •Participate in less than 1 h of exercise per week
- •Have not taken antibiotics in the last six months
排除标准
- •Men and women with fruits and vegetable intake exceeding 2 servings/day
- •Men and women with whole grain intakes exceeding 1 serving/day
- •Do not fit the inclusion criteria
研究组 & 干预措施
Control
3 servings of refined grains per day.
干预措施: Control (Other)
Fruits and Vegetables
5 servings of fruits and vegetable per day.
干预措施: Fruits and Vegetables (Other)
Whole Grain
3 servings of whole grains per day.
干预措施: Whole Grain (Other)
结局指标
主要结局
Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)
时间窗: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)
时间窗: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)
时间窗: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)
时间窗: 8 weeks
Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.
次要结局
- Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)(8 weeks)
- Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)(8 weeks)
- Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)(8 weeks)
研究者
Devin Rose
Associate Professor
University of Nebraska Lincoln