Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Plasma Glucose
研究概览
简要总结
This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum).
详细描述
Accumulating clinical evidence suggests positive effects of whole grain on cardiometabolic risk. However, outcomes of controlled trials indicate that substantial interpersonal variation occurs in these studies with regard to glucose homeostasis, with some persons being unaffected and others experiencing glucose-lowering effects due to whole wheat bread consumption. Whole grain (whole wheat) contains bioactive phytochemicals in addition to its well-recognized fiber content, and these constituents have not received adequate study to inform dietary recommendations. The objective of this study is to investigate the glucose-lowering effects of whole wheat bread in persons with prediabetes using multi-omics platforms that can provide an understanding of the complex interactions among the gut microbiome, gut metabolome, host metabolome, and gut barrier function. The hypothesis is that gut microbial metabolism of whole wheat and its major bioactive components is a determining factor of human health benefits. This will be tested by conducting a randomized, controlled crossover trial in persons with pre-diabetes who follow a controlled diet containing whole wheat bread or white bread for 2-weeks. Outcomes are expected to significantly advance an understanding of personalized, gut microbiome-mediated approaches in individuals with pre-diabetes to help guide dietary recommendations of whole wheat intake. In addition, novel evidence that maps out the differential functions of diverse genus/species of microbiota to biotransform whole wheat nutrients into more bioactive metabolites are expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting blood glucose between 100-125 mg/dL
- •BMI of 30-35 kg/m2
排除标准
- •History of liver disease, cardiovascular disease, overt diabetes, or cancer
- •Prescribed medications for hyperglycemia or dyslipidemia
- •Use of dietary supplements, prebiotics, or probiotics
- •Usage of antibiotics or anti-fungals within 3 months prior to enrollment
- •Alcohol consumption greater than 2 drinks per day
- •Aerobic exercise greater than 5 hours per week
- •Pregnancy or fertility treatments
- •History of chronically active inflammatory or neoplastic disease in 3 years prior to enrollment
- •History of chronic gastrointestinal disorder including diarrhea, inflammatory bowel disease, celiac disease; coagulation disorders, chronic immunosuppressive medication usage
- •History of myocardial infarction or cerebrovascular accident within 6 months prior to participation
结局指标
主要结局
Plasma Glucose
时间窗: Day 14 (0, 30, 60, 90, 120, 150, 180 minutes post oral glucose tolerance test)
Data are biomarker area under the time-concentration curve (0-3 hours) on day 14
次要结局
- Plasma Insulin(Day 14)
- Plasma Glucose(Day 14)
- Serum C-reactive Protein(Day 14)
- Serum Tumor Necrosis Factor Alpha(Day 14)
- Serum Interleukin-6(Day 14)
- Fecal Calprotectin(Day 14)
- Fecal Myeloperoxidase(Day 14)
- Urine Lactulose/Mannitol(Day 14)
- Urine Sucralose/Erythritol(Day 14)
- Serum Endotoxin(Day 14)
- Serum Myeloperoxidase(Day 14)
- Level of Toll-like Receptor 4 Gene Expression(Day 14)
- Myeloid Differentiation Factor 88 Gene Expression(Day 14)
- Tumor Necrosis Factor Alpha Gene Expression(Day 14)
- p65 Subunit of Nuclear Factor Kappa B Gene Expression(Day 14)
- Interleukin-6 Gene Expression(Day 14)
- Interleukin-8 Gene Expression(Day 14)
- Myeloperoxidase Gene Expression(Day 14)
- Monocyte Chemoattractant Protein-1 Gene Expression(Day 14)
- Fecal Butyrate(Day 14)
- Fecal Acetate(Day 14)
- Fecal Propionate(Day 14)
- Fecal Isobutyric Acid(Day 14)
- Fecal Isovaleric Acid(Day 14)
- Serum Alkylersorcinols(Day 14)
- Serum Benoxazinods(Day 14)
- Serum Phenolic Compounds(Day 14)
- Fecal Alkylresorcinols(Day 14)
- Fecal Benoxazinoids(Day 14)
- Fecal Phenolic Compounds(Day 14)
研究者
Richard Bruno
Principal Investigator
Ohio State University