This study aims to explore whether OMIF reconstructs the composition and function of the blood microbiome in healthy volunteers, through a cross-over trial, with secondary outcomes on the association of blood microbiome with fecal microbiome.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
The microbiome
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To explore the effect of OMIF on the blood archaea
Secondary outcome
To explore the effect of OMIF on the blood bacteria.
To explore the effect of OMIF on the blood viruses.
To explore the relationship between blood and gut microbiome.
Background summary
We previously demonstrated that the gut microbiome can be remodelled by one
month of intermittent fasting (OMIF) in healthy volunteers and animal models,
with impressive alteration observed in the overall composition and the
abundance of some dominated taxa that is further linked to the improvement of
liver function. The blood microbiome is a newly identified human microbiome
that is assumed to be more stable than the gut microbiome in the diagnosis and
prediction of liver cirrhosis and cancer. However, the effect of OMIF, as a
representative of lifestyle change on the blood microbiome remains elusive at
best.
Study objective
This study aims to explore whether OMIF reconstructs the composition and
function of the blood microbiome in healthy volunteers, through a cross-over
trial, with secondary outcomes on the association of blood microbiome with
fecal microbiome.
Study design
A cross-over trial
Intervention
a daily fasting from 7:30 h to 18:30 h for consecutive 30 days
Study burden and risks
It is expected that participants will have a reduced risk of liver disease and
chronic stress, harboring an increase of beneficial microbes in their feces
after OMIF, which can be collectively mirrored in the blood microbiome through
correlation analysis.
Doctor Molewaterplein 40 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Age 18-65 years
- 18.5 =< BMI < 25 kg/m2
- All genders
- Have not fasted (go for a day without any food) any days at least in the
previous one month
- Being willing to provide App-derived movement data over the course of the
study.
- Participants are willing to provide 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 (self-report)
- Chronic disease including type 2 diabetes, hypertension, fatty liver disease,
cancer
- Autoimmune disease (self-report and blood test)
- Internal disease including the gastrointestinal tract, lung, heart,
vasculature, liver and kidney
(self-report and blood test)
- Eating disorder or unconventional eating habits (self-report)
- Have a clinically significant abnormality as measured by a blood test
- In participation of other study
- Habit of performing regular fasting
- Women: pregnancy and breastfeeding
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85947.078.23 |