Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06678516

Intermittent Fasting on the Blood Microbiome

Led by Erasmus Medical Center · Updated on 2025-02-26

48

Participants Needed

2

Research Sites

5 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intermittent Fasting on the Blood Microbiome

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • Body mass index (BMI) between 18.5 and 25 kg/m2
  • All genders are eligible
  • Have not fasted (gone a day without food) for any days in the month before the study
  • Willing to provide movement data through an app during the study
  • Capable of giving written informed consent
Not Eligible

You will not qualify if you...

  • Regular use of medications like antibiotics, steroids, beta blockers, or adrenergic agents
  • Regular use of prebiotics or probiotics
  • Antibiotic use within the past month
  • Daily consumption of more than 10 cigarettes or more than 6 cups of coffee
  • Having chronic diseases such as type 2 diabetes, hypertension, fatty liver disease, cancer, or autoimmune disease
  • Internal diseases affecting gastrointestinal tract, lung, heart, blood vessels, liver, or kidneys
  • Eating disorders or unconventional eating habits
  • Clinically significant abnormal blood test results
  • Participation in another study
  • Habit of regular fasting
  • Pregnancy or breastfeeding (for women)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Northwest Minzu University

Lanzhou, Gansu, China, 730046

Actively Recruiting

2

Erasmus Medical Center - Department of Gastroenterology and Hepatology

Rotterdam, Netherlands, 3015 GD

Actively Recruiting

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Research Team

M

Maikel P Peppelenbosch, MD, PhD

CONTACT

J

Junhong Su

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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