NCT06678516 Intermittent Fasting on the Blood Microbiome
| NCT ID | NCT06678516 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-12-01 with a primary completion date of 2026-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Maikel P Peppelenbosch, MD, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06678516 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06678516 currently recruiting?
Yes, NCT06678516 is actively recruiting participants. Contact the research team at m.peppelenbosch@erasmusmc.nl for enrollment information.
Where is the NCT06678516 trial being conducted?
This trial is being conducted at Lanzhou, China, Rotterdam, Netherlands.
Who is sponsoring the NCT06678516 clinical trial?
NCT06678516 is sponsored by Erasmus Medical Center. The principal investigator is Maikel P Peppelenbosch, MD, PhD at Erasmus Medical Center. The trial plans to enroll 48 participants.