Safety and Clinical Efficiency of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases
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|ClinicalTrials.gov Identifier: NCT03193177|
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fasting Chronic Disease Autoimmune Diseases Metabolic Disease High Blood Pressure Fatty Liver Kidney Stone Gall Stone Hysteromyoma||Other: the 21-day fasting-like diet||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single group will be recruited to participate in the 21-day fasting diet.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Open Label, Phase I/II Clinical Trial of the 21-day Fasting-like Diet in Patients With Metabolic and Autoimmune Diseases|
|Actual Study Start Date :||June 20, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: 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
a fasting-like diet with 400 KJ energy intake per day for 21 days
Other Name: Bigu
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193177
|Contact: Minghui Zhang, PhDemail@example.com|
|Nanshan Branch of Qilu Hospital||Recruiting|
|Longkou, Shandong, China, 265706|
|Contact: Liping Wang, Master 86-535-8779176 firstname.lastname@example.org|
|Study Director:||Ligang Ming, MD||Nanshan Branch of Qilu Hospital|