An observational study in Fasting, Chronic Disease and Autoimmune Diseases, sponsored by Tsinghua University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Tsinghua University · Observational
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.
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.
86 studies on the registry are indexed under Fasting; 38 are open to participants now.
This study's enrollment of 144 is above the median of 100 across 20 observational studies indexed under Fasting.
Browse Fasting studies →Tsinghua University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Of these 144 participants, 55 were male and 89 were female. For detailed information, please follow our recent publications.
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Exclusion Criteria:
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
Also known as: Bigu
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.
Time frame: 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.
Time frame: 30 days after the fasting-like diet
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.
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.
Stool samples were collected in time if possible and analyzed by RNA-seq for the composition of the intestinal microflora.
Time frame: Baseline, 4 days, 7 days, 14 days, 21 days, 51 days after the beginning of the fasting-like diet
Plan to share: Yes
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Tsinghua University