StressMoodBugs HDACNCT06546683
Brain Responses to Short-Chain Fatty Acid Intervention
A study testing Short-Chain Fatty Acids in people with Stress and Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Healthy Volunteers
- What is being tested?
- Short-Chain Fatty Acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 14Show fewer
- 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")
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Short-Chain Fatty Acid Intervention on Affective Brain Circuits and Neuroepigenetics
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.
Read the 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 histone-deacetylase (HDAC)-inhibiting properties of SCFAs are the main mechanism underlying SCFA-induced changes in stress, cognition and behavior.
Primary objective: to test the effect of colon-delivered SCFA intervention versus placebo on HDAC expression in the brain and neural responses to stress
Secondary objective: to determine the effects of colon-delivered SCFA administration versus placebo on inflammatory and autonomic responses to stress and to determine the mediating and/or moderating factors that potentially underlie SCFA-induced changes to stress responses (HDAC expression in stress-responsive regions, serum SCFA levels)
To this end, 32 participants will be asked to undergo a pre- and post-intervention visit, separated by one week intervention with either colon-delivered SCFAs or placebo (16 per group). During the study visits, participants undergo simultaneous PET-MR imaging with [11C]Martinostat. They undergo the Montreal Imaging Stress Test (MIST) and the Maastricht Acute Stress Test (MAST) at each visit.
- Conditions
- Stress, Healthy Volunteers
- Being tested
- Short-Chain Fatty Acids, Placebo
- Keywords
- Short-Chain Fatty Acids, Acute Stress, Microbiota-Gut-Brain-Axis, Neuroepigenetics, [11C] Martinostat, Functional magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Chain Fatty AcidsOther
Colon-delivery capsules of Short-Chain Fatty Acids will be administered in a ratio of 60:20:20, thus 150 mmol of acetate, 50 mmol of propionate and 50 mmol of butyrate equivalent to 20g of fibers, once daily, one week
PlaceboOther
Microcrystalline Cellulose will be used as placebo, one daily, one week
| Study group | Role | What they receive |
|---|---|---|
| Short-Chain Fatty Acids | Experimental | SCFAs will be delivered directly to the colon using pH-dependent colon delivery capsules Receives: Other: Short-Chain Fatty Acids |
| Placebo | Placebo comparator | Colon-delivery capsules of microcrystalline cellulose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDAC expression
Brain HDAC expression will be quantified using the PET radiotracer [11C]Martinostat before and after the intervention
Measured: Throughout study completion, on average 2 years
Brain response to stress
Brain response (brain oxygenation level-dependent signals) to a fMRI-adapted stress task will be measured before and after intervention
Measured: Throughout study completion, on average 2 years
Secondary outcomes (9)
Brain metabolite concentration
Relative quantification of brain metabolites (mmol/L) using 1H-Magnetic Resonance Spectroscopy before and after intervention
Measured: Throughout study completion, on average 2 years
Serum short-chain fatty acid levels
Quantification of serum SCFA (μM) before and after intervention
Measured: Throughout study completion, on average 2 years
Salivary cortisol response to stress
Biological stress sensitivity is measured by quantifying cortisol levels (ng/ml) from multiple saliva samples taken before, during, and after a stress task performed during the pre-intervention and post-intervention visit
Measured: Throughout study completion, on average 2 years
Cytokine levels
Quantification of inflammatory cytokines (pg/ml) before and after intervention
Measured: Throughout study completion, on average 2 years
C-reactive protein levels
Quantification of hs-C-reactive protein levels (ng/ml) before and after intervention
Measured: Throughout study completion, on average 2 years
Heart rate variability
Assessing heart rate variability (ms) with ECG before and after intervention
Measured: Throughout study completion, on average 2 years
Blood pressure
Assessing blood pressure (systolic/diastolic mmHg) with a blood pressure monitor before and after intervention
Measured: Throughout study completion, on average 2 years
Heartbeat
Assessing heartbeat (bpm) with a blood pressure monitor before and after intervention
Measured: Throughout study completion, on average 2 years
Self-reported stress
Psychological stress sensitivity is measured through stress reports of the participants using the visual analogue scale (VAS). VAS scorings are taken before, during, and after a stress task performed during the pre-intervention and post-intervention visit.
Measured: Throughout study completion, on average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Van Oudenhove, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Lukas Van Oudenhove, MD, PhD, Principal investigator, KU LeuvenAnnalena Fuchs, MSc, Study director, KU LeuvenKristin Verbeke, Pharm, PhD, Principal investigator, KU LeuvenBoushra Dalile, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546683
- Sponsor's protocol ID
- S68154
- Acronym
- MoodBugs HDAC
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Short-Chain Fatty Acid Intervention on Affective Brain Circuits and Neuroepigenetics
- ClinicalTrials.gov ID
- NCT06546683
- Acronym / sponsor ID
- MoodBugs HDAC / S68154
- Conditions
- Stress, Healthy Volunteers
- Keywords
- Short-Chain Fatty Acids, Acute Stress, Microbiota-Gut-Brain-Axis, Neuroepigenetics, [11C] Martinostat, Functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 histone-deacetylase (HDAC)-inhibiting properties of SCFAs are the main mechanism underlying SCFA-induced changes in stress, cognition and behavior.
Primary objective: to test the effect of colon-delivered SCFA intervention versus placebo on HDAC expression in the brain and neural responses to stress
Secondary objective: to determine the effects of colon-delivered SCFA administration versus placebo on inflammatory and autonomic responses to stress and to determine the mediating and/or moderating factors that potentially underlie SCFA-induced changes to stress responses (HDAC expression in stress-responsive regions, serum SCFA levels)
To this end, 32 participants will be asked to undergo a pre- and post-intervention visit, separated by one week intervention with either colon-delivered SCFAs or placebo (16 per group). During the study visits, participants undergo simultaneous PET-MR imaging with [11C]Martinostat. They undergo the Montreal Imaging Stress Test (MIST) and the Maastricht Acute Stress Test (MAST) at each visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-Chain Fatty Acids | Experimental | Other: Short-Chain Fatty AcidsSCFAs will be delivered directly to the colon using pH-dependent colon delivery capsules |
| Placebo | Placebo comparator | Other: PlaceboColon-delivery capsules of microcrystalline cellulose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-Chain Fatty AcidsColon-delivery capsules of Short-Chain Fatty Acids will be administered in a ratio of 60:20:20, thus 150 mmol of acetate, 50 mmol of propionate and 50 mmol of butyrate equivalent to 20g of fibers, once daily, one week | Other | Short-Chain Fatty Acids |
| PlaceboMicrocrystalline Cellulose will be used as placebo, one daily, one week | Other | Placebo |
Primary outcome
HDAC expression
Time frame: Throughout study completion, on average 2 years
Brain HDAC expression will be quantified using the PET radiotracer [11C]Martinostat before and after the intervention
Brain response to stress
Time frame: Throughout study completion, on average 2 years
Brain response (brain oxygenation level-dependent signals) to a fMRI-adapted stress task will be measured before and after intervention
9 secondary outcomes
Brain metabolite concentration
Time frame: Throughout study completion, on average 2 years
Serum short-chain fatty acid levels
Time frame: Throughout study completion, on average 2 years
Salivary cortisol response to stress
Time frame: Throughout study completion, on average 2 years
Cytokine levels
Time frame: Throughout study completion, on average 2 years
C-reactive protein levels
Time frame: Throughout study completion, on average 2 years
Heart rate variability
Time frame: Throughout study completion, on average 2 years
Blood pressure
Time frame: Throughout study completion, on average 2 years
Heartbeat
Time frame: Throughout study completion, on average 2 years
Self-reported stress
Time frame: Throughout study completion, on average 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lukas Van Oudenhove, MD, PhD principal investigator
KU Leuven
Annalena Fuchs, MSc study director
KU Leuven
Kristin Verbeke, Pharm, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-Chain Fatty Acids in people with Stress and Healthy Volunteers, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Van Oudenhove, MD, PhD (+32 16 33 01 47, lukas.vanoudenhove@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDAC expression (time frame: Throughout study completion, on average 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.