Effects of intermittent fasting on the blood microbiome
The Effect of One Month of Intermittent Fasting on the Blood Microbiome in Healthy Volunteers
This study is testing how intermittent fasting might change the bacteria in the blood of healthy people to see if it can improve liver health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 2 sites (Lanzhou, Gansu and 1 other locations) |
| Trial ID | NCT06678516 on ClinicalTrials.gov |
What this trial studies
This study investigates how intermittent fasting can alter the composition and function of the blood microbiome in healthy volunteers. It builds on previous findings that intermittent fasting can remodel the gut microbiome and aims to explore similar effects in the blood microbiome, which may provide insights into liver health. The study employs a randomized controlled cross-over design, allowing participants to serve as their own controls. Secondary outcomes will also be assessed to evaluate additional health impacts.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-65 with a BMI between 18.5 and 25 who have not fasted in the month prior to the study.
Not a fit: Patients with chronic diseases such as type 2 diabetes, hypertension, or cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into how dietary changes like intermittent fasting can improve liver function and overall health.
How similar studies have performed: While studies have shown success in altering the gut microbiome through intermittent fasting, the effects on the blood microbiome remain largely untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lanzhou, Gansu and 1 other locations
- Northwest Minzu University — Lanzhou, Gansu, China (Recruiting)
- Erasmus Medical Center - Department of Gastroenterology and Hepatology — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Maikel P Peppelenbosch, MD, PhD — Erasmus Medical Center
- Study coordinator: Maikel P Peppelenbosch, MD, PhD
- Email: m.peppelenbosch@erasmusmc.nl
- Phone: +31 07032792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.