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Intermittent Fasting on the Blood Microbiome

Sponsor: Erasmus Medical Center • ClinicalTrials.gov ID: NCT06678516

Registry updated: 2026-09-11

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Description

The investigators previously demonstrated that the gut microbiome can be remodeled by one month of intermittent fasting (OMIF) in healthy volunteers and animal models, with a notable alteration observed in its overall composition which could be linked to improvement in liver function. The blood microbiome, which mirrors the human ecosystem and includes all microbes mainly including bacteria, archaea, and viruses, is a new-identified human microbiome assessment tool that is assumed to be more stable and representative than the gut microbiome, with substantial potential for the diagnosis and prediction of liver cirrhosis and cancer. However, the effect of OMIF, which mimics lifestyle change typically advised in liver disease, on this blood microbiome remains elusive at best. The aim of this study is to explore whether OMIF remodels the composition and function of the blood microbiome in healthy volunteers, through a Randomized controlled cross-over trial, with secondary outcomes on the association of blood microbiome with the gut microbiome.

Interventions

Intermittent fasting (Dietary supplement)
Participants are asked to abstain from any form of fasting or calorie restriction in one month of the study (which is also a pre-fasting washout for those volunteers that might be performing forms of fasting before the study) and then start with one month of intermittent fasting, with daily fasting duration from 7:30 to 18:30. Food is abstained from during fasting, only water and zero-calorie drinks like black coffee and unsweetened tea are allowed.

Eligibility criteria

Inclusion Criteria: * Age 18-65 years * 18.5 =\< BMI \< 25 kg/m2 * All genders are included. * Have not fasted (go for a day without any food) for any amount of days in the month before the start of the study * Being willing to provide App-derived movement data over the course of the study * Participants are willing to and capable of providing written informed consent. Exclusion Criteria: * Regular use medications such as antibiotics, steroids, beta blockers, and adrenergic-stimulating agents (self-report) * Regular use prebiotic and/or probiotics (self-report) * Intake of antibiotic at least in previous 1 months (self-report) * Daily consumption of \>10 cigarettes, or \>6 cups of coffee (the latter because of the effects on circadian rhythm). (self-report) * Chronic diseases including type 2 diabetes, hypertension, fatty liver disease, cancer, or autoimmune disease (self-report and clinical chemistry) * Internal diseases, including those of the gastrointestinal tract, lung, heart, vasculature, liver, and kidney (self-report and clinical chemistry) * Eating disorder or unconventional eating habits (self-report) * Have a clinically significant abnormality as measured by a blood test * Participation in another study (self-report) * Habit of performing regular fasting (self-report) * Women: pregnancy and breastfeeding (self-report)

Conditions

Healthy

Locations

Northwest Minzu University — Lanzhou, Gansu, China
Erasmus Medical Center - Department of Gastroenterology and Hepatology — Rotterdam, Netherlands

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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