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

September 3, 2019 updated by: Minghui Zhang, Tsinghua University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Longkou, Shandong, China, 265706
        • Nanshan Branch of Qilu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: the 21-day fasting-like diet
a fasting-like diet with 400 KJ energy intake per day for 21 days
Other Names:
  • Bigu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame: 30 days after the fasting-like diet
Phase I: To obtain preliminary estimates of the safety of the fasting-like diet.
30 days after the fasting-like diet
Evaluation of the therapeutic effects on metabolic disorder-associated diseases by the examination of metabolic biomarkers.
Time Frame: 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.
30 days after the fasting-like diet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional changes in the peripheral blood lymphocytes pre and post fasting-like diet as accesse by flow cytometry and RNA-seq.
Time Frame: 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.
Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet
Compositional changes in intestinal microflora pre and post fasting-like diet as accesse by RNA-seq.
Time Frame: 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.
Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tsinghua University

Collaborators

Nanshan Branch of Qilu Hospital

Investigators

  • Study Director: Ligang Ming, MD, Nanshan Branch of Qilu Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2017

Primary Completion (ACTUAL)

August 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (ACTUAL)

June 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THUMED-BG-170612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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