N/A
N=10
PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02409784 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet — 0.672; 4.83 µmol/100g/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pre-KD (Dietary_supplement); Post-KD (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Université de Sherbrooke
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet |
0.672; 4.83 | — |
| PRIMARY Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet |
31.58; 24.46 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- Healthy adults
- No signs of cognitive impairment
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT02409784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.