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

Completed

• Conditions: Fatty Liver; Kidney Stone; Fasting; Gall Stone; Autoimmune Diseases; Metabolic Disease; Chronic Disease; High Blood Pressure; Hysteromyoma
• Interventions: Other: the 21-day fasting-like diet

• Registration Number: NCT03193177
• Lead Sponsor: Tsinghua University

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.

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-19
• Study Start: 2017-06-20
• Study First Posted: 2017-06-20
• Primary Completion: 2018-08-31
• Study Completion: 2018-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the 21-day fasting-like diet	the 21-day fasting-like diet	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nanshan Branch of Qilu Hospital; 🇨🇳 Longkou, Shandong, China