A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases

Conditions
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Fasting, Chronic Disease, Autoimmune Diseases, Metabolic Disease, High Blood Pressure, Fatty Liver, Kidney Stone, Gall Stone, Hysteromyoma

Intervention / Treatment
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* Other: the 21-day fasting-like diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the 21-day fasting-like diet<br>Participants will be supplied with fasting-like diet containing only 5% of normal calorie intake. Physical examinations will be performed on day 0, 4,7,14,21 and 51 after the clinical trial. | Other: the 21-day fasting-like diet<br>* a fasting-like diet with 400 KJ energy intake per day for 21 days<br>* Other names: Bigu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | Phase I: To obtain preliminary estimates of the safety of the fasting-like diet. | 30 days after the fasting-like diet | 
| Evaluation of the therapeutic effects on metabolic disorder-associated diseases by the examination of metabolic biomarkers. | Phase II: To compare the state of diseases pre and post fasting-like diet by the examination of comprehensive metabolic panel. | 30 days after the fasting-like diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional changes in the peripheral blood lymphocytes pre and post fasting-like diet as accesse by flow cytometry and RNA-seq. | 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. | 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. | Stool samples were collected in time if possible and analyzed by RNA-seq for the composition of the intestinal microflora. | Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting-like diet, chronic diseases, autoimmune diseases, metabolic disorder