Status:
NOT_YET_RECRUITING
Brain Responses to Short-Chain Fatty Acid Intervention
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Stress
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
A randomized, triple-blind, placebo-controlled study on the effect of colon-delivered short-chain fatty acids (SCFAs) on neural responses to stress and neuroepigenetics.
Detailed Description
The goal of this interventional study is to study the underlying mechanism of the attenuating effect of colon-delivered SCFAs on the cortisol response to stress. Pre-clinical studies suggest that the ...
Eligibility Criteria
Inclusion
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Proficiency in English and/or Dutch
- Access to a -18°C freezer (i.e. ordinary household freezer)
- Male participants
- Age 18-45 years
- BMI 18.5-25 kg/m2
Exclusion
- Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol (as assessed by medical staff on the research team)
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the study
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Current or recent (3-month) medication use (especially antibiotics, cardiovascular drugs, steroids, non-steroid anti-inflammatory drugs, centrally effective drugs)
- Current or recent (1-month) infection (e.g. common cold, influenza, COVID-19, etc.)
- Recent (1-month) vaccination (e.g. flu shot, SARS-COV-2 vaccine, etc)
- Smoking
- Night-shift work
- Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten- free, etc.)
- Use of pre- or probiotics within one month preceding the study
- Previous experience with any of the tasks used in the study (not including questionnaires)
- Neuroimaging contraindications
- If the participant invokes that he does not want to be informed of eventual pathology that might be found during imaging (invokes the "right not to know")
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06546683
Start Date
September 1 2024
End Date
December 1 2026
Last Update
August 9 2024
Active Locations (1)
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1
UZ/KU Leuven
Leuven, Belgium, 3000