Intermittent Fasting on the Blood Microbiome

Recruiting now · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT06678516

Run by

Erasmus Medical Center

People needed

48

Starts

2025-12-01

Expected to finish

2026-01-10

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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