The Effect of Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Changes in Gut microbiota diversity
研究概览
简要总结
The chestnut tree (Castanea sativa Mill.) is a species widely cultivated in Portugal, which is a major producer of chestnuts. Nuts are nutritionally interesting, not only because of their content of vitamins, minerals, and phytochemicals but also of their high fiber content.
Fiber, as it is not digested by humans, has a preponderant role in the intestinal microbiota, for its maintenance, and, consequently, has an impact on metabolic status.
The inclusion of foods rich in these components, and with extensive local production, can be an excellent strategy for improving the metabolic parameters of the population.
The main objective of this single group assignment clinical trial is to evaluate the effect of including roasted chestnuts in the daily diet on the composition and diversity of the intestinal microbiota. It is also intended to evaluate metabolic parameters to determine the impact of this intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian.
- •Filling informed consent.
- •Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.
排除标准
- •Chestnut sensibility.
- •Chestnut daily consumption in the month before the study initiation.
- •Having taken antibiotics within the 6 months prior to beginning the study;
- •Use of pro/prebiotics or fiber as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
- •Use of laxative 6 weeks before recruitment.
- •Specific dietary regimen (e.g., vegan).
- •Specific nutritional therapy (e.g. high protein).
- •Excessive alcohol consumption.
- •Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease or Diabetes Mellitus.
- •Use of proton pump inhibitors, antidiabetic drugs, insulin, or statins.
- •Pregnant or breastfeeding.
- •Participation in another clinical trial within the last 3 months.
结局指标
主要结局
Changes in Gut microbiota diversity
时间窗: 14 days
Difference in Gut microbiota Shannon index, from baseline to the end of intervention
Changes in Gut microbiota characterization
时间窗: 14 days
Difference in Gut microbiota taxonomic characterization, from baseline to the end of intervention
次要结局
- Changes in LDL cholesterol(14 days)
- Changes in fecal LPS(14 days)
- Changes in breath CH4(14 days)
- Changes in IL-1b(14 days)
- Changes in adiponectin(14 days)
- Changes in leptin(14 days)
- Changes in HOMA-IR(14 days)
- Changes in fasting glucose(14 days)
- Changes in high sensitivity PCR(14 days)
- Changes in fecal acetate(14 days)
- Changes in total cholesterol(14 days)
- Changes in breath H2(14 days)
- Changes in fecal butyrate(14 days)
- Changes in fecal ALP(14 days)
- Changes in TNFa(14 days)