Β-OHB Supplementation and Brain Health in Older Adults
NCT06588946, Phase 2, Not yet recruiting, McMaster University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Β-OHB Supplementation and Brain Health in Older Adults | ClinicalTrials.gov |
| NCT number | NCT06588946 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | McMaster University | ClinicalTrials.gov |
| Conditions | Subjective Cognitive Decline | ClinicalTrials.gov |
| Interventions | Ketone monoester (KME) supplement, Placebo supplement | ClinicalTrials.gov |
| First posted | 2024-09-19 | ClinicalTrials.gov |
| Last updated | 2025-02-26 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Global cerebral blood flow (gCBF) | Baseline and post-intervention (i.e., 14-days later) for both KME and placebo conditions | Measured by magnetic resonance imaging (MRI) under resting, normocapnic conditions. Arterial flow measurement will be performed using a phase contrast flow sensitizing MRI pulse sequence. Cross-sectional areas and mean blood flow of the carotid and vertebral arteries will be measured, with total blood flow in all four vessels equaling global CBF. | ClinicalTrials.gov |
| Primary | Resting-state functional connectivity | Baseline and post-intervention (i.e., 14-days later) for both KME and placebo conditions | A resting state functional magnetic resonance imaging (rsfMRI) scan will be performed eyes closed using a gradient echo EPI sequence. The temporal and regional co-activation of brain regions in the resting state provide a measure of functional connectivity in the brain. rsfMRI data will be analyzed to measure global whole-brain functional connectivity and within localized brain regions of interest. | ClinicalTrials.gov |
| Secondary | Cognitive testing | Baseline and post-intervention (i.e., 14-days later) for both KME and placebo conditions | A battery of computerized validated psychometric tests will be used, including: the Mnemonic similarities task (MST) to assess hippocampal-dependent learning and memory, the Stroop colour-word task to assess processing speed, working memory, attention, and inhibitory control, and a shortened version of the Odd-One-Out test to measure working memory and executive function. A non-computerized dual-task test will be performed to assess the multitasking ability of walking while performing another cognitive task. | ClinicalTrials.gov |
| Secondary | Microstructural white matter health | Baseline and post-intervention (i.e., 14-days later) for both KME and placebo conditions | Dual spin echo, echo-planar imaging (EPI) diffusion tensor imaging (DTI) sequence collected by magnetic resonance imaging (MRI) to assess brain white matter microstructural integrity. | ClinicalTrials.gov |
| Secondary | Cerebrovascular reactivity | Baseline and post-intervention (i.e., 14-days later) for both KME and placebo conditions | The phase contrast flow sensitizing MRI pulse and resting state functional MRI sequences will both be repeated while participants undergo an elevated CO2 breathing task. Cerebrovascular function will be calculated from the stimulus-response relationship between PaCO2 and (1) phase contrast: cross sectional areas of the internal carotid and vertebral arteries, and (2) rsfMRI: % change BOLD/mmHg. | ClinicalTrials.gov |
| Secondary | Blood-borne biomarkers | Baseline and post-intervention (i.e., 14-days later) for both KME and placebo conditions | A venous blood sample will be collected to assess circulating concentrations of various hormones and metabolites (e.g., brain-derived neurotrophic factor \[BDNF\]) that relate to brain health, metabolism, and inflammation. | 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 31
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 11045239 | BACKGROUND | PubMed |
| 15817019 | BACKGROUND | PubMed |
| 16576330 | BACKGROUND | PubMed |
| 20083042 | BACKGROUND | PubMed |
| 20332511 | BACKGROUND | PubMed |
| 20368517 | BACKGROUND | PubMed |
| 21130529 | BACKGROUND | PubMed |
| 21228297 | BACKGROUND | PubMed |
| 22683129 | BACKGROUND | PubMed |
| 23223453 | BACKGROUND | PubMed |
| 24267647 | BACKGROUND | PubMed |
| 24798886 | BACKGROUND | PubMed |
| 27458340 | BACKGROUND | PubMed |
| 28814282 | BACKGROUND | PubMed |
| 29489818 | BACKGROUND | PubMed |
| 30197300 | BACKGROUND | PubMed |
| 30643288 | BACKGROUND | PubMed |
| 31597601 | BACKGROUND | PubMed |
| 31821157 | BACKGROUND | PubMed |
| 31958406 | BACKGROUND | PubMed |
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 1
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 |
|---|---|---|
| Stroop Color-Word 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)