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

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193177
• Other study ID #: THUMED-BG-170612
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: Tsinghua University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chronic Disease
• Fasting
• Fatty Liver
• Gall Stone
• Gallstones
• High Blood Pressure
• Hypertension
• Hysteromyoma
• Kidney Calculi
• Kidney Stone
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• the 21-day fasting-like diet
a fasting-like diet with 400 KJ energy intake per day for 21 days

Locations

Country	Name	City	State
China	Nanshan Branch of Qilu Hospital	Longkou	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Tsinghua University	Nanshan Branch of Qilu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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