A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
研究概览
简要总结
Effectiveness of fasting or fasting-mimicking diet has been proved an effective approach to treat metabolic and autoimmune diseases in mice. However, clinical trials performing prolonged fasting with more than 7 days have not been reported. Investigators conduct an open label, phase I/II clinical trial to evaluate the safety and effectiveness of the 21-day fasting-like diet in the treatment of metabolic and autoimmune diseases.
详细描述
Although fasting has been proved an effective approach to treat metabolic and autoimmune diseases in mice, prolonged fasting is difficult to implement in human-beings for the safety and feasibility reasons.
In this clinical trial, we will recruit metabolic and autoimmune diseases and then follow a traditional Chinese 21-day fasting-like diet process with extremely low calorie intake (about 5% of normal diet) and prolonged fasting-like period. Blood, urine, stool samples will be collected on day 0 (baseline), day 4, day 7, day 14, day 21 and day 51 after it started up. Therefore we can examine the changes of disease-associated physical indexes and metabolic biomarkers pre and post the 21-day fasting-like diet.
The purpose of the study is to ascertain the impact of the fasting-like diet during the 21 days. The investigators hypothesize that the 21-day fasting-like diet can reduce the biomarkers associated with aging and age-related diseases and benefit for the treatment of metabolic and autoimmune diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged ≥18 and ≤75 years;
- •Subjects has a confirmed diagnosis of metabolic and autoimmune diseases, including high blood pressure, kidney stone, gall stone, hysteromyoma, fatty liver, psoriasis, and so on.
排除标准
- •Subjects has a confirmed diagnosis of cancer;
- •Females who are pregnant or nursing;
- •Subject requires a prescheduled regularly administration of drugs;
- •Subject has severe renal insufficiency;
- •Subject has cardiac arhythmia.
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
时间窗: 30 days after the fasting-like diet
Phase I: To obtain preliminary estimates of the safety of the fasting-like diet.
Evaluation of the therapeutic effects on metabolic disorder-associated diseases by the examination of metabolic biomarkers.
时间窗: 30 days after the fasting-like diet
Phase II: To compare the state of diseases pre and post fasting-like diet by the examination of comprehensive metabolic panel.
次要结局
- Functional changes in the peripheral blood lymphocytes pre and post fasting-like diet as accesse by flow cytometry and RNA-seq.(Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet)
- Compositional changes in intestinal microflora pre and post fasting-like diet as accesse by RNA-seq.(Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet)
研究者
Minghui Zhang
Associate Professor
Tsinghua University