Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact email@example.com.
Long-Term Extreme Fasting Following a Traditional Chinese 'Bigu' Regimen: A Preliminary Retrospective and Prospective Cohort Study
39 Pages Posted: 26 Sep 2018More...
Background: Fasting has long been a ritual or practice in varied religions, and recently, has been noticed to reduce the risk factors of metabolic diseases. In China, varied populations performed a traditional Taoism fasting practice, called Bigu regimen, which lasted for 21-day with <5% calorie intake. However, the safety and applicability of this procedure haven not been investigated.
Methods: A total of 144 volunteered participants in six camps following the 21-day fasting (with <5% of normal diet) were investigated. 124 were examined for physical biomarkers and 53 of which also had biochemical markers. Another open label, non-comparative, phase 1/2 prospective cohort study enrolling 20 participants with metabolic diseases was also performed. The physical indices, biochemical biomarkers and gut microbiota were collected at varied point of the fasting procedure. Statistical comparison and metagenomic analysis were performed. This study was registered in ClinicalTrials.gov (NCT03193177).
Findings: Our preliminary retrospective cohort study showed that no severe adverse event (grade 3 or above) was reported, and all biomarkers fluctuated within the safe ranges, except for the urea acid. The 21-day fasting could significantly reduce BMI and blood pressures. The prospective cohort study of the metabolic diseased participants showed a significant reduction of BMI (3.3±1.0) and systolic blood pressure (28.7±17.8 mmHg) after the fasting procedure. The data also presented significant ameliorations on overweight (16/16), hypertension (11/11) and fatty liver (9/9). Obvious structural alteration of gut microbiota was also observed during the fasting procedure.
Interpretation: The 21-day fasting appeared safe and feasible for both healthy and unhealthy people. It could ameliorate the risk factors associated with hypertension and hyperlipidemia. Meanwhile, it could help to reform and/or reconstruct the structure of gut microbiota.
Funding: This work was supported by National Natural Science Foundation of China and China Overseas-Educated Scholars Development Foundation.
Declaration of Interest: We declare that we have no conflicts of interest.
Ethical Approval: All recruited participants have signed voluntary informed consent for collection and analysis of blood and fecal microbiome samples under Institutional Review Board (IRB)–approved protocols (THUMED-BG-170612).
Suggested Citation: Suggested Citation