Menu
Not yet recruiting NCT06546683

Brain Responses to Short-Chain Fatty Acid Intervention

No phase Interventional Stress Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Short-Chain Fatty Acids, Placebo.
Who it may be relevant to
Registry conditions: Stress, Healthy Volunteers. Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of a Short-Chain Fatty Acid Intervention on Affective Brain Circuits and Neuroepigenetics

Overview

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.

Interventions

  • Other Short-Chain Fatty Acids
    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
  • Other Placebo
    Microcrystalline Cellulose will be used as placebo, one daily, one week

Primary outcome measures

  • HDAC expression [Time frame: Throughout study completion, on average 2 years]
  • Brain response to stress [Time frame: Throughout study completion, on average 2 years]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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")

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • UZ/KU Leuven — Leuven

Identifiers

NCT: NCT06546683 · S68154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗