Autoimmune Diseases, Chronic Disease, Fasting, Fatty Liver, Gall Stone, High Blood Pressure, Hysteromyoma, Kidney Stone, Metabolic Disease
Conditions
Keywords
fasting-like diet, chronic diseases, autoimmune diseases, metabolic disorder
Brief summary
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.
Detailed description
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.
Interventions
OTHERthe 21-day fasting-like diet
a fasting-like diet with 400 KJ energy intake per day for 21 days
Sponsors
Nanshan Branch of Qilu Hospital
Tsinghua University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Peripheral blood samples were collected at indicated time points and analyzed by flow cytometry for the composition of lymphocyte subsets and by RNA-seq for their functions. |
| 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 | Stool samples were collected in time if possible and analyzed by RNA-seq for the composition of the intestinal microflora. |
Countries
China
Outcome results
None listed