Proof of Mechanism of a New Ketogenic Supplement Using Dual Tracer PET (Positron Emission Tomography)
NCT02551419, Not applicable, Completed, Université de Sherbrooke
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Proof of Mechanism of a New Ketogenic Supplement Using Dual Tracer PET (Positron Emission Tomography) | ClinicalTrials.gov |
| NCT number | NCT02551419 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 82 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Université de Sherbrooke | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | ketogenic drink, placebo | ClinicalTrials.gov |
| First posted | 2015-09-16 | ClinicalTrials.gov |
| Last updated | 2020-03-26 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in global ketone (11C-AcAc) uptake in grey matter | Baseline and 6 months of intervention | The change in brain ketone uptake will be quantified by PET and expressed as cerebral metabolic rate of AcAc (CMR-A) | ClinicalTrials.gov |
| Primary | Change in plasma ketone | Baseline and 6 months of intervention | The change in plasma ketone will be measure to obtain a ketone chronic response | ClinicalTrials.gov |
| Secondary | Change in global brain FDG uptake in grey matter (CMR-G) | Baseline and 6 months of intervention | The change in brain glucose uptake will be quantified by PET and expressed as cerebral metabolic rate of glucose (CMR-G) | ClinicalTrials.gov |
| Secondary | Change in regional CMR-A | Baseline and 6 months of intervention | The change in brain ketone uptake will be quantified by PET in different regions of the brain | ClinicalTrials.gov |
| Secondary | regional brain volumes by vMRI | Baseline and 6 months of intervention | Change in brain volume measure by MRI | ClinicalTrials.gov |
| Secondary | Change in cognitive status - episodic memory | Baseline and 6 months of intervention | Change in episodic memory assessed by the 16-item free/cued word learning (Buschke and Grober test- Z score of trial 1, 2, 3 and delay) and the Brief Visuospatial Memory Test-revised (Z score of trial 1) | ClinicalTrials.gov |
| Secondary | Change in cognitive status- language domain | Baseline and 6 months of intervention | Change in language assessed by Boston Naming Test (Z score) | ClinicalTrials.gov |
| Secondary | Change in cognitive status - executive function | Baseline and 6 months of intervention | Change in executive function assessed by condition 4 of the trail making test, condition 3 and 4 of the Stroop test and the 4 conditions of verbal fluency test (all Z score) | ClinicalTrials.gov |
| Secondary | Change in cognitive status - processing speed | Baseline and 6 months of intervention | Change in processing speed assessed by global score of Digit Span (WAIS III), Digit Symbol (WAIS III), condition 1 and 2 of Stroop test and condition 1,2,3,5 of the trail making test (all Z score) | ClinicalTrials.gov |
| Secondary | Blood metabolite profile triglycerides | Baseline and 6 months of intervention | Changes in Triglycerides (mM) | ClinicalTrials.gov |
| Secondary | Blood metabolite profile Glucose | Baseline and 6 months of intervention | Changes in Glucose (mM) | ClinicalTrials.gov |
| Secondary | Blood metabolite profile cholesterol | Baseline and 6 months of intervention | Changes in Total cholesterol (mM) | ClinicalTrials.gov |
| Secondary | Derived cerebral metabolic rate of total ketones | Baseline and 6 months of intervention | Cerebral metabolic rate of total ketone derived from ketone PET (dCMRket, μmol/100 g/min) | ClinicalTrials.gov |
| Secondary | Pharmacokinetic ketone response (phase 2) | Baseline and 6 months of intervention | Area under the curve of pharmacokinetic of blood ketone | 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 5
The papers the trial lists on ClinicalTrials.gov.
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 6
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 |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | 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)