The Addition of Whole Grains to the Diets of Adults: A Study of Digestive Health and Natural Defenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- change in Lymphocyte proliferation
研究概览
简要总结
The purpose of this study is to determine if substituting whole grains for refined grains in the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria in the gut, and has beneficial effects on immune function, digestive health, cardiovascular health, regulation of body weight and composition, and vitamin K status.
The investigators hypothesize that whole grain consumption over a period of 6 weeks will alter the gut microflora toward a more beneficial bacterial profile, improve the immune response while reducing oxidative stress and inflammatory markers, have favorable effects on factors influencing the regulation of body weight and composition,increase bacterial vitamin K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption, vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is hypothesized that, consumption of whole grains will alter statin pharmacokinetics by decreasing rate of statin absorption, resulting in more sustained plasma concentrations.
详细描述
This study is a randomized parallel-arm trial using a six-week dietary intervention following a 2 week run-in period. Healthy volunteers will be randomized to two groups (n=40/group), and consume either a diet rich in whole grains or a diet rich in refined grains provided at estimated energy requirements for 6 weeks. Outcomes will be measured during the run-in period and at week 6 of the intervention. To control for variation in microbiota an additional 10 volunteers will serve as "negative controls" and not undergo any diet intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
change in Lymphocyte proliferation
时间窗: week 2 of washout diet and week 6 of diet intervention
Whole blood collected at baseline (week 2 of washout period) and at week-6 of the diet intervention will be investigated for the ability of lymphocytes to proliferate by quantifying the incorporation of tritium following mitogen stimulation.
change in T Cell-mediated immunity
时间窗: week 2 of washout diet and week 6 of diet intervention
Delayed-type hypersensitivity (DTH) and lymphocyte proliferation will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention to assess adaptive immune function, specifically T cell-mediated immunity.
change in Natural Killer Function
时间窗: week 2 of washout diet and week 6 of diet intervention
The ability of peripheral blood mononuclear cells to bind and kill leukemia cells will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention
change in Salivary immunoglobulin A (IgA)
时间窗: week 2 of washout diet and week 6 of intervention diet
Salivary IgA will be analyzed at baseline (week 2 of washout period) and at week-6 of the diet intervention.
change in Cytokines
时间窗: week 2 of washout diet and week 6 of diet intervention
Peripheral blood and stool samples will be analyzed at baseline (week 2 of washout diet) and week-6 of diet intervention for cytokines.
次要结局
- change in vitamin K status(week 2 of washout diet and week 6 of intervention diet)
- change in body composition(week 2 of washout diet and week 6 of intervention diet)
- change in appetite(Weekly for 8 weeks)
- change in glycemic regulation(week 2 of washout diet and week 6 of intervention diet)
- change in quality of life(week 2 of washout diet and week 6 of intervention diet)
- change in stool pH(week 2 of washout diet and week 6 of intervention diet)
- change in total stool anaerobic and aerobic bacterial counts(week 2 of washout diet and week 6 of intervention diet)
- change in stool energy content(week 2 of washout diet and week 6 of intervention diet)
- change in cardiovascular health risk factors(week 2 of washout diet and week 6 of intervention diet)
- change in resting energy metabolism(week 2 of washout diet and week 6 of intervention diet)
- change in breath hydrogen and methane(week 2 of washout diet and week 6 of intervention diet)
- change in 72hr fecal weight(week 2 of washout diet and week 6 of intervention diet)
- change in stool water content(week 2 of washout diet and week 6 of intervention diet)
- change in DNA methylation(week 2 of washout diet and week 6 of intervention diet)
- change in gut microbiota composition(week 2 of washout diet and week 6 of intervention diet)
- change in fasting gut hormone concentration(week 2 of washout diet and week 6 of intervention diet)
- change in fasting serum leptin(week 2 of washout diet and week 6 of intervention diet)
- change in eating behaviors(week 2 of washout diet and week 6 of intervention diet)
- change in concentrations of the cholesterol synthesis (squalene, desmosterol, lathosterol) and absorption (campesterol, sitosterol, cholestanol) markers(week 2 of washout diet and week 6 of intervention diet)
- change in serum vitamin D(week 2 of washout diet and week 6 of intervention diet)
研究者
Simin Meydani
Director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts
Tufts University