Brain Responses to Short-Chain Fatty Acid Intervention
NCT Number: NCT06546683
Acronym: MoodBugs HDAC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Healthy Volunteers
Interventions: OTHER: Short-Chain Fatty Acids|OTHER: Placebo
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: MALE
Age: ADULT
Enrollment: 32
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2026-12
Locations: UZ/KU Leuven, Leuven, 3000, Belgium

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.

Primary Outcome Measures: HDAC expression, Brain HDAC expression will be quantified using the PET radiotracer \[11C\]Martinostat before and after the intervention, 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, Throughout study completion, on average 2 years
Secondary Outcome Measures: Brain metabolite concentration, Relative quantification of brain metabolites (mmol/L) using 1H-Magnetic Resonance Spectroscopy before and after intervention, Throughout study completion, on average 2 years|Serum short-chain fatty acid levels, Quantification of serum SCFA (μM) before and after intervention, 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, Throughout study completion, on average 2 years|Cytokine levels, Quantification of inflammatory cytokines (pg/ml) before and after intervention, Throughout study completion, on average 2 years|C-reactive protein levels, Quantification of hs-C-reactive protein levels (ng/ml) before and after intervention, Throughout study completion, on average 2 years|Heart rate variability, Assessing heart rate variability (ms) with ECG before and after intervention, Throughout study completion, on average 2 years|Blood pressure, Assessing blood pressure (systolic/diastolic mmHg) with a blood pressure monitor before and after intervention, Throughout study completion, on average 2 years|Heartbeat, Assessing heartbeat (bpm) with a blood pressure monitor before and after intervention, 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., Throughout study completion, on average 2 years
Other Outcome Measures: Fecal gut microbiota profile, Assessing gut microbiota profile before and after intervention, Throughout study completion, on average 2 years|Perceived Stress Scale (PSS), Assessing ratings on PSS. PSS scores range between 0-40 with higher scores indicating worse outcome, Throughout study completion, on average 2 years|Gastrointestinal Symptom Rating Scale (GSRS), Assessing ratings on the subscales of GSRS and its total score. It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores indicates a worse outcome., Throughout study completion, on average 2 years|Big Five Inventory 10 (BFI-10), Measuring the Big Five personality traits, including Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness., Throughout study completion, on average 2 years|Generic Assessment of Side Effects, General side effects will be assessed and recorded in a structured, validated approach using the Generic Assessment of Side Effects (GASE)54. The GASE consists of 36 items asking for most frequently reported side effects for drugs based on the FDA adverse event reporting system database from all countries. Symptoms of all body parts during the last seven days will be self-reported and rated based on severity from 0 (not present) to 3 (severe)., Throughout study completion, on average 2 years|State-Trait-Anxiety Inventory (STAI), Assessing momentary (state) anxiety during the pre- and post-intervention visit. This inventory is part of the State-Trait Anxiety Inventory (STAI) with 20 questions specifically for state anxiety, rated on a 4-point scale. State anxiety is rated with anxiety absent and anxiety present questions. Anxiety absent questions constitute the absence of anxiety in a statement like, "I feel secure." Anxiety present questions represent the presence of anxiety in a statement like "I feel worried." The 4-point scale are as follows: 1 'not at all', 2 'somewhat', 3 'moderately so', and 4 'very much so'., Throughout study completion, on average 2 years|Emotion Regulation Questionnaire (ERQ), designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression, Throughout study completion, on average 2 years|Pittsburgh Sleep Quality Index (PSQI), an instrument to measure the quality and patterns of sleep in adults. . It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month., Throughout study completion, on average 2 years|The Cognitive Assessment Questionnaire (CAQ), to assess the frequency with which people experience cognitive failures, such as absent-mindedness, in everyday life - slips and errors of perception, memory and motor functioning. The questionnaire has 25 items which are scored from Never (0), Very rarely (1), Occasionally (2), Quite often (3) to Very often (4). A total score as well as three subscales (Forgetfulness, Distractibility, False Triggering) can be calculated., Throughout study completion, on average 2 years|Mainz Inventory for Microstressors (MIMIS), retrospective assessment of microstressors over one week covering both stressor occurence and perceived stressor intensity, Throughout study completion, on average 2 years