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Clinical Trials/NCT02409784
NCT02409784CompletedNot Applicable

PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis

Université de Sherbrooke0 sites10 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Primary Endpoint
Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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

Intervention: Pre-KD (Dietary Supplement)

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

Intervention: Post-KD (Dietary Supplement)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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