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

Tsinghua University

Status: Completed

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

Treatments: Other: the 21-day fasting-like diet

Study type: Observational

Funder types: Other

Identifiers

NCT03193177

THUMED-BG-170612

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

144 participants in 1 patient group

the 21-day fasting-like diet

Description:

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.

Treatment:

Other: the 21-day fasting-like diet