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Safety and Clinical Efficiency of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases

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ClinicalTrials.gov Identifier: NCT03193177
Recruitment Status : Unknown
Verified June 2017 by Minghui Zhang, Tsinghua University.
Recruitment status was:  Recruiting
First Posted : June 20, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Nanshan Branch of Qilu Hospital
Information provided by (Responsible Party):
Minghui Zhang, Tsinghua University

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.

Condition or disease Intervention/treatment Phase
Fasting Chronic Disease Autoimmune Diseases Metabolic Disease High Blood Pressure Fatty Liver Kidney Stone Gall Stone Hysteromyoma Other: the 21-day fasting-like diet Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single group will be recruited to participate in the 21-day fasting diet.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Phase I/II Clinical Trial of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 Name: Bigu




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193177


Contacts
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Contact: Minghui Zhang, PhD 86-13240905431 mh-zhang@mail.tsinghua.edu.cn

Locations
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China, Shandong
Nanshan Branch of Qilu Hospital Recruiting
Longkou, Shandong, China, 265706
Contact: Liping Wang, Master    86-535-8779176    wangliping@nanshan.com.cn   
Sponsors and Collaborators
Tsinghua University
Nanshan Branch of Qilu Hospital
Investigators
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Study Director: Ligang Ming, MD Nanshan Branch of Qilu Hospital

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Responsible Party: Minghui Zhang, Associate Professor, Tsinghua University
ClinicalTrials.gov Identifier: NCT03193177     History of Changes
Other Study ID Numbers: THUMED-BG-170612
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Minghui Zhang, Tsinghua University:
fasting-like diet
chronic diseases
autoimmune diseases
metabolic disorder

Additional relevant MeSH terms:
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Fatty Liver
Gallstones
Kidney Calculi
Nephrolithiasis
Hypertension
Metabolic Diseases
Autoimmune Diseases
Chronic Disease
Liver Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Gallbladder Diseases