Skip to main content
OpenTrials
Completed

NCT Number: NCT03193177

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fasting Autoimmune Diseases Behavior Biliary Tract Diseases Calculi Cardiovascular Diseases Cholecystolithiasis Cholelithiasis Chronic Disease Digestive System Diseases Disease Attributes Fatty Liver Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gall Stone Gallbladder Diseases Gallstones High Blood Pressure Hypertension Hysteromyoma Immune System Diseases Kidney Calculi Kidney Diseases Kidney Stone Liver Diseases Male Urogenital Diseases Metabolic Disease Metabolic Diseases Nephrolithiasis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanshan Branch of Qilu Hospital

Longkou, Shandong, 265706, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the 21-day fasting-like diet

Other

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

Other names: Bigu

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tsinghua University

Other

Collaborators

  • Nanshan Branch of Qilu Hospital

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.