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

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.

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Key information

Conditions

Healthy Acid-Base Imbalance Acidosis Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-KD

Dietary Supplement

Before starting 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet

Post-KD

Dietary Supplement

After 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Acronym: TEP-KD

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 7, 2015
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed