Intermittent Fasting on the Blood Microbiome

NCT06678516 | Recruiting DMC

• 1 other identifier: NL85947.078.23
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Healthy

Keywords

Intermittent fasting; The blood microbiome; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change in blood Archaea

  Change in blood Archaea after OMIF versus ad libitum diets will be measured with shotgun sequencing technology.

  One month

Secondary Outcomes (3)

• Change in blood bacteria

  One month

• Changes in blood viruses

  One month

• The relationship between the blood and gut microbiome

  One month

Other Outcomes (7)

• Change in BMI

  One month

• Change in systolic and diastolic blood pressure

  One month

• Changes in circulating concentrations of liver enzymes alanine transaminase, aspartate aminotransferase, gamma-glutamyl transferase and alkaline phosphatase

  One month

Study Arms (2)

Intermittent fasting

EXPERIMENTAL

One month of intermittent fasting.

Dietary Supplement: Intermittent fasting

Ad libitum diets

NO INTERVENTION

One month of ad libitum diets (no fasting and/or restriction).

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.

Also known as: OMIF

Intermittent fasting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• =\< 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (2)

Northwest Minzu University

Lanzhou, Gansu, 730046, China

RECRUITING

Erasmus Medical Center - Department of Gastroenterology and Hepatology

Rotterdam, 3015 GD, Netherlands

RECRUITING

Related Publications (1)

• Su J, Hansen BE, Ma Z, Peppelenbosch MP. Effects of one month of intermittent fasting on the blood microbiome in healthy volunteers (OMIF): A randomized controlled crossover study protocol. Contemp Clin Trials. 2025 Aug;155:107986. doi: 10.1016/j.cct.2025.107986. Epub 2025 Jun 15.

  PMID: 40527395 DERIVED

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Maikel P Peppelenbosch, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Maikel P Peppelenbosch, MD, PhD

  Erasmus Medical Center

  STUDY CHAIR

Central Study Contacts

Maikel P Peppelenbosch, MD, PhD

CONTACT

+31 07032792; m.peppelenbosch@erasmusmc.nl

Junhong Su

CONTACT

j.su.1@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Model Details: This study is a randomized, cross-over trial with healthy participants aged 18-65 years. Following random order, participants must go through two study periods: one month of intermittent fasting and ad libitum diet (no restrictions), respectively, with one month of washout period following the first study period before participants cross over to the second study period. Since the intervention is performing/not performing fasting, the participants cannot be blinded. The participants are instructed and guided through the interventions and before randomization will sign the PIF.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); NL (1)