A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Met… (NCT03193177) | Clinical Trial Compass
CompletedNot Applicable
A Retrospective and Prospective Cohort Study of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
China144 participantsStarted 2017-06-20
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Timeframe: 30 days after the fasting-like diet
2
Evaluation of the therapeutic effects on metabolic disorder-associated diseases by the examination of metabolic biomarkers.