Short-Chain Fatty Acids in Lypopolysaccharide-Induced Inflammation and Executive Function
NCT07713641, Not applicable, Recruiting, Universitaire Ziekenhuizen KU Leuven
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Short-Chain Fatty Acids in Lypopolysaccharide-Induced Inflammation and Executive Function | ClinicalTrials.gov |
| NCT number | NCT07713641 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 56 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven | ClinicalTrials.gov |
| Conditions | Endotoxemia, Inflammation, Executive Function (Cognition) | ClinicalTrials.gov |
| Interventions | Short-Chain Fatty Acid Colon-Delivery Capsules, Placebo capsules, Lipopolysaccharide (LPS) | ClinicalTrials.gov |
| First posted | 2026-07-20 | ClinicalTrials.gov |
| Last updated | 2026-07-20 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Serum interleukin-6 (IL-6) response to the LPS challenge | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, and 6 hours after LPS injection | Effect of SCFA versus placebo on the systemic inflammatory response to experimental endotoxemia, indexed by serum IL-6 concentrations measured at serial timepoints across the test day following the intravenous LPS bolus. The primary analysis evaluates the treatment-by-timepoint interaction on the IL-6 time course using a linear mixed model, with treatment (SCFA vs. placebo) as a between-subject factor and timepoint as a within-subject factor. | ClinicalTrials.gov |
| Secondary | Serum pro- and anti-inflammatory cytokine response to the LPS challenge | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, and 6 hours after LPS injection | Effect of SCFA versus placebo on serum concentrations of TNF-alpha, IL-1-beta, IFN-gamma, IL-8, IL-4, and IL-10. Analyzed as treatment-by-timepoint interactions using linear mixed models. | ClinicalTrials.gov |
| Secondary | High-sensitivity C-reactive protein (hs-CRP) response to the LPS challenge | 2 hours before LPS injection, and at 2, 6, and 24 hours after LPS injection | Effect of SCFA versus placebo on serum high-sensitivity C-reactive protein (hs-CRP) concentrations, measured at selected timepoints on the test day and at the 24-hour follow-up visit. | ClinicalTrials.gov |
| Secondary | LPS-induced sickness behaviour (SicknessQ) | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, and 6 hours after LPS injection | Effect of SCFA versus placebo on subjective sickness behaviour, assessed with the Sickness Questionnaire (SicknessQ), analyzed across timepoints on the test day. | ClinicalTrials.gov |
| Secondary | Body temperature response to the LPS challenge | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, and 6 hours after LPS injection | Effect of SCFA versus placebo on body temperature (degrees Celsius). | ClinicalTrials.gov |
| Secondary | Heart rate response to LPS challenge | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, and 6 hours after LPS injection | Effect of SCFA versus placebo on heart rate (beats per minute) across the monitoring period. | ClinicalTrials.gov |
| Secondary | Blood pressure response to the LPS challenge | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, and 6 hours after LPS injection | Effect of SCFA versus placebo on systolic and diastolic blood pressure (mmHg). | ClinicalTrials.gov |
| Secondary | Salivary cortisol response to the LPS challenge | At 0, 1, 2, 3, 4, and 6 hours after LPS injection | Effect of SCFA versus placebo on salivary cortisol concentrations (ng/ml). | ClinicalTrials.gov |
| Secondary | Plasma ACTH | At 0, 1, 2, 3, 4, and 6 hours after LPS injection | Effect of SCFA versus placebo on plasma ACTH concentrations (ng/l) | ClinicalTrials.gov |
| Secondary | Working memory performance (3-back task) | 2 hours before LPS injection, 2.25 hours after LPS injection, and 24 hours after LPS injection | Effect of SCFA versus placebo on working memory, assessed with the 3-back task (primary index: d-prime). Assessed at baseline (pre-LPS), post-LPS on the test day, and at the 24-hour follow-up. | ClinicalTrials.gov |
| Secondary | Response inhibition (Stop Signal Task) | 2 hours before LPS injection, 2.25 hours after LPS injection, and 24 hours after LPS injection | Effect of SCFA versus placebo on response inhibition, assessed with the Stop Signal Task (outcome: stop-signal reaction time, SSRT, in milliseconds). | ClinicalTrials.gov |
| Secondary | Cognitive flexibility - task switching (Number-Letter task) | 2 hours before LPS injection, 2.25 hours after LPS injection, and 24 hours after LPS injection | Effect of SCFA versus placebo on cognitive flexibility, assessed with the Number-Letter task (outcome: switch cost, in milliseconds). | ClinicalTrials.gov |
| Secondary | Cognitive inhibition (Stroop task) | 2 hours before LPS injection, 2.25 hours after LPS injection, and 24 hours after LPS injection | Effect of SCFA versus placebo on cognitive inhibition, assessed with the Stroop task (outcome: congruency effect, in milliseconds). | ClinicalTrials.gov |
| Secondary | Cognitive flexibility - set shifting (Wisconsin Card Sorting Task) | 2 hours before LPS injection, 2.25 hours after LPS injection, and 24 hours after LPS injection | Effect of SCFA versus placebo on cognitive flexibility, assessed with the Wisconsin Card Sorting Task (outcome: number of perseverative errors). | ClinicalTrials.gov |
| Secondary | Systemic SCFA uptake (serum SCFA concentrations) | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, and 6 hours after LPS injection | Serum concentrations of acetate, propionate, and butyrate, assessed as a measure of systemic SCFA uptake to confirm target engagement of the colon-delivery intervention, and used as a mediator in mechanistic analyses of treatment effects on the inflammatory response. | ClinicalTrials.gov |
| Other | Baseline gut microbiota composition | Single fecal sample collected within the 3 days prior to the test day | Baseline fecal gut microbiota composition, characterized by quantitative microbiome profiling from a single fecal sample collected before the test day. Examined in exploratory analyses as a baseline predictor of inter-individual variability in systemic SCFA uptake and treatment response. | ClinicalTrials.gov |
| Other | Mood - valence (MDMQ) | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, 6 and 24 hours after LPS injection | Effect of SCFA versus placebo on self-reported mood valence (good-bad dimension), assessed with the Multidimensional Mood Questionnaire (MDMQ/MDBF). Score range 1-40; higher scores indicate a more positive mood. | ClinicalTrials.gov |
| Other | Mood - alertness (MDMQ) | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, 6 and 24 hours after LPS injection | Effect of SCFA versus placebo on self-reported alertness (awake-tired dimension), assessed with the Multidimensional Mood Questionnaire (MDMQ/MDBF). Score range 1-40; higher scores indicate greater alertness. | ClinicalTrials.gov |
| Other | Mood - calmness (MDMQ) | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, 6 and 24 hours after LPS injection | Effect of SCFA versus placebo on self-reported calmness (calm-restless dimension), assessed with the Multidimensional Mood Questionnaire (MDMQ/MDBF). Score range 1-40; higher scores indicate greater calmness. | ClinicalTrials.gov |
| Other | Negative affect (PANAS) | 2 hours before LPS injection, and at 0, 1, 2, 3, 4, 5, 6 and 24 hours after LPS injection | Effect of SCFA versus placebo on self-reported negative affect, assessed with the negative affect subscale of the Positive and Negative Affect Schedule (10 items, 5-point Likert; score range 10-50). Higher scores indicate greater negative affect. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Stop-Signal Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)