UZ/KU Leuven
Leuven, 3000, Belgium
Location contact
Lukas Van Oudenhove, MD, PhD
CONTACT
NCT Number: NCT06546683
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.
Trial opening soon.
Get Notified18 year–45 year
Male
Interventional
Not applicable
Leuven, 3000, Belgium
Lukas Van Oudenhove, MD, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Microcrystalline Cellulose will be used as placebo, one daily, one week
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
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
Time frame: Throughout study completion, on average 2 years
Relative quantification of brain metabolites (mmol/L) using 1H-Magnetic Resonance Spectroscopy before and after intervention
Time frame: Throughout study completion, on average 2 years
Quantification of serum SCFA (μM) before and after intervention
Time frame: Throughout study completion, on average 2 years
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
Time frame: Throughout study completion, on average 2 years
Quantification of inflammatory cytokines (pg/ml) before and after intervention
Time frame: Throughout study completion, on average 2 years
Quantification of hs-C-reactive protein levels (ng/ml) before and after intervention
Time frame: Throughout study completion, on average 2 years
Assessing heart rate variability (ms) with ECG before and after intervention
Time frame: Throughout study completion, on average 2 years
Assessing blood pressure (systolic/diastolic mmHg) with a blood pressure monitor before and after intervention
Time frame: Throughout study completion, on average 2 years
Assessing heartbeat (bpm) with a blood pressure monitor before and after intervention
Time frame: Throughout study completion, on average 2 years
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.
Time frame: Throughout study completion, on average 2 years
Assessing gut microbiota profile before and after intervention
Time frame: Throughout study completion, on average 2 years
Assessing ratings on PSS. PSS scores range between 0-40 with higher scores indicating worse outcome
Time frame: Throughout study completion, on average 2 years
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.
Time frame: Throughout study completion, on average 2 years
Measuring the Big Five personality traits, including Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness.
Time frame: Throughout study completion, on average 2 years
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).
Time frame: Throughout study completion, on average 2 years
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'.
Time frame: Throughout study completion, on average 2 years
designed to assess individual differences in the habitual use of two emotion regulation strategies: cognitive reappraisal and expressive suppression
Time frame: Throughout study completion, on average 2 years
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.
Time frame: Throughout study completion, on average 2 years
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.
Time frame: Throughout study completion, on average 2 years
retrospective assessment of microstressors over one week covering both stressor occurence and perceived stressor intensity
Contact information is provided by the study sponsor or research team.
Universitaire Ziekenhuizen KU Leuven
Other
The Effect of a Short-Chain Fatty Acid Intervention on Affective Brain Circuits and Neuroepigenetics
Acronym: MoodBugs HDAC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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