FastingNCT03193177
A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
An observational study of Fasting and Chronic Disease, run by Tsinghua University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Chronic Disease, Autoimmune Diseases
- What is being tested?
- the 21-day fasting-like diet
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Of these 144 participants, 55 were male and 89 were female. For detailed information, please follow our recent publications.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fasting, Chronic Disease, Autoimmune Diseases, Metabolic Disease, High Blood Pressure, Fatty Liver
- Being tested
- the 21-day fasting-like diet
- Keywords
- fasting-like diet, chronic diseases, autoimmune diseases, metabolic disorder
- Medical subject headings
- Fasting, Chronic Disease, Autoimmune Diseases, Metabolic Diseases, Hypertension, Fatty Liver, Kidney Calculi, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the 21-day fasting-like dietOther
Also called Bigu
a fasting-like diet with 400 KJ energy intake per day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: the 21-day fasting-like diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Stool samples were collected in time if possible and analyzed by RNA-seq for the composition of the intestinal microflora.
Measured: Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start20 Jun 2017
- Primary completion31 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanshan Branch of Qilu Hospital
- Responsible party
- Principal investigator, Minghui Zhang, Tsinghua University
- Investigators
- Ligang Ming, MD, Study director, Nanshan Branch of Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193177
- Sponsor's protocol ID
- THUMED-BG-170612
- Status last verified
- Sep 2019
- First submitted
- 12 Jun 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT03193177
- Acronym / sponsor ID
- THUMED-BG-170612
- Conditions
- Fasting, Chronic Disease, Autoimmune Diseases, Metabolic Disease, High Blood Pressure, Fatty Liver
- Keywords
- fasting-like diet, chronic diseases, autoimmune diseases, metabolic disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Collaborators
- Nanshan Branch of Qilu Hospital
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the 21-day fasting-like diet | – | Other: the 21-day fasting-like dietParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Of these 144 participants, 55 were male and 89 were female. For detailed information, please follow our recent publications.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the 21-day fasting-like dietAlso: Bigua fasting-like diet with 400 KJ energy intake per day for 21 days | Other | the 21-day fasting-like diet |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ligang Ming, MD study director
Nanshan Branch of Qilu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Chronic Disease, run by Tsinghua University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. (time frame: 30 days after the fasting-like diet). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.