HealthyTEP-KDNCT02409784
PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
A study testing Pre-KD and Post-KD in people with Healthy, run by Université de Sherbrooke.
Trial summary
Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of aging-related cognitive impairment in humans. Ketones are the main alternative energy substrate to glucose for the brain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pre-KD and Post-KD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- No signs of cognitive impairment
Who cannot join
- Not within the age limits
- Pregnancy or breast feeding
- Incapacity to withstand a supine position for 40 min
- Non lacunar infarction
- Known psychiatric history of schizophrenia, psychotic disorders, major affective disorders (bipolar disorder and major depression <5 years), panic disorder, obsessive compulsive disorders and other conditions that may affect memory
- Epilepsy, brain trauma with loss of consciousness, subarachnoid hemorrhage
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- History of alcool and/or substances abuse (excessive alcool consumption ≥10 drinks/weeks)
- Parkinson disease
- Down syndrome
- Inflammatory disease
- Abnormal blood pressure, liver or kidney function, blood count
- Dyslipidemia, hypothyroidism, osteoporosis
- Presence of a metal object in the body
About this study
Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of aging-related cognitive impairment in humans. Ketones are the main alternative energy substrate to glucose for the brain. Several studies show that brain ketone uptake and metabolism are unaltered in cognitively-normal older persons and in Alzheimer's disease (AD). Nutritional ketosis is reported to have a positive impact on cognitive performances in mild cognitive impairment and AD. Nevertheless, changes in regional brain glucose and ketone uptake in adults are poorly understood during diet-induced experimental ketosis. The investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be directly correlated with the elevation of blood ketone levels and inversely correlated to brain glucose uptake.
- Conditions
- Healthy
- Being tested
- Pre-KD, Post-KD
- Keywords
- Brain metabolism, Ketones, Ketogenic diet, TEP scan
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-KDDietary supplement
Before starting 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet
Post-KDDietary supplement
After 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Pre/Post TEP study with a 4 days ketogenic diet (KD).
Interventions 1: Pre-KD = Participants did a TEP before starting the 4-day diet
Intervention 2: Post-KD = Participants did a TEP after completing the 4-day diet Receives: Dietary Supplement: Pre-KD; Dietary Supplement: Post-KD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet
Measured: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet
Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet
Measured: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ten participants received a very high fat ketogenic diet (KD) (4.5:1; lipid:protein plus carbohydrates) for four days.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen C Cunnane, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409784
- Sponsor's protocol ID
- 13-214
- Acronym
- TEP-KD
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2015
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
- ClinicalTrials.gov ID
- NCT02409784
- Acronym / sponsor ID
- TEP-KD / 13-214
- Conditions
- Healthy
- Keywords
- Brain metabolism, Ketones, Ketogenic diet, TEP scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 6 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of aging-related cognitive impairment in humans. Ketones are the main alternative energy substrate to glucose for the brain. Several studies show that brain ketone uptake and metabolism are unaltered in cognitively-normal older persons and in Alzheimer's disease (AD). Nutritional ketosis is reported to have a positive impact on cognitive performances in mild cognitive impairment and AD. Nevertheless, changes in regional brain glucose and ketone uptake in adults are poorly understood during diet-induced experimental ketosis. The investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be directly correlated with the elevation of blood ketone levels and inversely correlated to brain glucose uptake.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ten participants received a very high fat ketogenic diet (KD) (4.5:1; lipid:protein plus carbohydrates) for four days.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Dietary Supplement: Pre-KD, Dietary Supplement: Post-KDPre/Post TEP study with a 4 days ketogenic diet (KD). Interventions 1: Pre-KD = Participants did a TEP before starting the 4-day diet Intervention 2: Post-KD = Participants did a TEP after completing the 4-day diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- No signs of cognitive impairment
Key exclusion criteria (13 listed)
- Not within the age limits
- Pregnancy or breast feeding
- Incapacity to withstand a supine position for 40 min
- Non lacunar infarction
- Known psychiatric history of schizophrenia, psychotic disorders, major affective disorders (bipolar disorder and major depression <5 years), panic disorder, obsessive compulsive disorders and other conditions that may affect memory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-KDBefore starting 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet | Dietary supplement | Ketogenic diet |
| Post-KDAfter 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet | Dietary supplement | Ketogenic diet |
Primary outcome
Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet
Time frame: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet
Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet
Time frame: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen C Cunnane, PhD principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
A study testing Pre-KD and Post-KD in people with Healthy, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet (time frame: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.