The Effect of Dietary Fructose on Gut Microbiota and Hepatosteatosis in Healthy Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change of microbiota
研究概览
简要总结
The consumption of sugar-sweetened beverages (SSB) has increased steadily over the past decades, resulting in the dramatic increase of fructose intake as it is one of the main ingredients of artificial sweeteners. Recently, large epidemiological studies have documented the association between a high-fructose-diet and hepatic steatosis, and other metabolic disorders. So it is interesting for scientists to explore the underlying mechanism. This study aims to investigate the effect of dietary fructose and gut microbiota and the hepatosteatosis in healthy men. Serum and fecal metabolomics will be investigated.
详细描述
This is a single center, randomized, controlled study. 60 healthy men will be recruited according to the inclusion criteria. All subjects are randomly allocated to Group A and Group B, who orally takes 75g and 150g fructose daily respectively. Subjects in Group A will be instructed to drink fructose solution containing 75g fructose per day, and those in Group B will be instructed to drink fructose solution containing 150g fructose per day. The intervention will last four weeks. The anthropomentric data will be collect with questionnaire and serum and fecal samples collected at baseline and the end of the intervention. The effect and mutual interaction of dietary fructose and microbiota will be explored. The effect of dietary fructose on hepatosteatosis will be investigated as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men aged from 18 to 40 (including both ends);
- •Body mass index (BMI) ranges from 18.5 to 23.9 kg/m2 (including both ends);
- •The body weight has not changed dramatically in the past 3 months (±3kg);
排除标准
- •Subjects who have received antibiotic-related treatment, proton pump inhibitor treatment, or glucocorticoid hormone treatment within 1 month before enrollment;
- •Subjects with diabetes or cardiovascular disease or other chronic diseases who require long-term medication;
- •Subjects who suffered from an acute gastrointestinal diseases within the past month, or who have an history of chronic gastrointestinal disease or hepatitis;
- •Subjects with a history of gastrointestinal surgery;
- •Subjects with abnormal liver or kidney function, or severe cardiovascular diseases;
- •Subjects with mental disorders or impaired cognitive function;
- •Poor compliance;
- •Participates enrolled in other clinical research at the same time;
- •Other unsuitable occasions judged by clinicians..
结局指标
主要结局
Change of microbiota
时间窗: 4 weeks
The change of microbiota in fecal samples from baseline to the end of the study
Change of intra-hepatic triglyceride content(IHTG)
时间窗: 4 weeks
The IHTG will be measured using MRI-PDFF
次要结局
- The change of serum proinflammatory factors(4 weeks)
- Change of serum metabolomics(4 weeks)
研究者
Xiaoying Li
Director
Shanghai Zhongshan Hospital