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

NCT03193177 | Completed DMC

• 1 other identifier: THUMED-BG-170612
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  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.

  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 Outcomes (2)

• Functional changes in the peripheral blood lymphocytes pre and post fasting-like diet as accesse by flow cytometry and RNA-seq.

  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.

  Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet

Study Arms (1)

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

Interventions

the 21-day fasting-like diet OTHER

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

Also known as: Bigu

the 21-day fasting-like diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tsinghua University: lead
• Nanshan Branch of Qilu Hospital: collaborator

Study Sites (1)

Nanshan Branch of Qilu Hospital

Longkou, Shandong, 265706, China

Location

MeSH Terms

Conditions

Fasting; Chronic Disease; Autoimmune Diseases; Metabolic Diseases; Hypertension; Fatty Liver; Kidney Calculi; Gallstones

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Cholelithiasis; Biliary Tract Diseases; Cholecystolithiasis; Gallbladder Diseases

Study Officials

• Ligang Ming, MD

  Nanshan Branch of Qilu Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 20, 2017
• Study Start: June 20, 2017
• Primary Completion: August 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)