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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02409784
Acronym
TEP-KD
Enrollment
10
Registered
2015-04-07
Start date
2014-03-31
Completion date
2015-01-31
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Brain metabolism, Ketones, Ketogenic diet, TEP scan

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.

Interventions

DIETARY_SUPPLEMENTPre-KD

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

DIETARY_SUPPLEMENTPost-KD

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

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Ten participants received a very high fat ketogenic diet (KD) (4.5:1; lipid:protein plus carbohydrates) for four days.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic DietAt 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 DietAt baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet

Participant flow

Recruitment details

Participant were recruited with advertising poster on bulletin board of different local organism (university, health clinic, sport and leisure association, etc)

Participants by arm

ArmCount
Ketogenic Diet
TEP study following a 4 day ketogenic diet (KD) Intervention 1: Pre-KD = Participants did a TEP before starting a 4 days ketogenic diet Intervention 2: Post-KD = Participants did a TEP after 4 days of ketogenic diet
10
Total10

Baseline characteristics

CharacteristicKetogenic Diet
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Age, Continuous34 years
STANDARD_DEVIATION 15
Region of Enrollment
Canada
10 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
Ketogenic DietMean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic DietPre-KD0.672 µmol/100g/minStandard Error 0.18
Ketogenic DietMean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic DietPost-KD4.83 µmol/100g/minStandard Error 0.75
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
Ketogenic DietMean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic DietPre-KD31.58 µmol/100g/minStandard Error 3.02
Ketogenic DietMean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic DietPost-KD24.46 µmol/100g/minStandard Error 5.47

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026