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

NCT ID: NCT03193177

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

the 21-day fasting-like diet

Intervention Type: OTHER

a fasting-like diet with 400 KJ energy intake per day for 21 days

Interventions

the 21-day fasting-like diet

a fasting-like diet with 400 KJ energy intake per day for 21 days

Intervention Type: OTHER

Other Intervention Names

Bigu

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanshan Branch of Qilu Hospital

UNKNOWN

Sponsor Role: collaborator

Tsinghua University

OTHER

Sponsor Role: lead

Responsible Party

Minghui Zhang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ligang Ming, MD

Role: STUDY_DIRECTOR

Nanshan Branch of Qilu Hospital

Locations

Nanshan Branch of Qilu Hospital

Longkou, Shandong, China

Countries

China

Other Identifiers

THUMED-BG-170612

Identifier Type: -

Identifier Source: org_study_id