Clinical trial NCT03193177: A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
Official title: A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Chronic Disease
Autoimmune Diseases
Metabolic Disease
High Blood Pressure
Fatty Liver
Kidney Stone
Gall Stone
Hysteromyoma
Keywords: fasting-like diet
chronic diseases
autoimmune diseases
metabolic disorder
Lead sponsor: Tsinghua University
Sponsor class: OTHER
Collaborators: name: Nanshan Branch of Qilu Hospital
First posted: 2017-06-20
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Of these 144 participants, 55 were male and 89 were female. For detailed information, please follow our recent publications.

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.

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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: 30 days after the fasting-like diet
measure: Evaluation of the therapeutic effects on metabolic disorder-associated diseases by the examination of metabolic biomarkers.
timeFrame: 30 days after the fasting-like diet
Secondary outcomes:
measure: Functional changes in the peripheral blood lymphocytes pre and post fasting-like diet as accesse by flow cytometry and RNA-seq.
timeFrame: Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet
measure: Compositional changes in intestinal microflora pre and post fasting-like diet as accesse by RNA-seq.
timeFrame: Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet
Other outcomes:
Locations:
city: Longkou
country: China
facility: Nanshan Branch of Qilu Hospital
state: Shandong
Study officials:
affiliation: Nanshan Branch of Qilu Hospital
name: Ligang Ming, MD
role: STUDY_DIRECTOR
References: