PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis (TEP-KD)
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pre-KD
Post-KD
Sponsored by
About this trial
This is an interventional basic science trial for Healthy focused on measuring Brain metabolism, Ketones, Ketogenic diet, TEP scan
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ketogenic diet
Arm Description
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
Outcomes
Primary Outcome Measures
Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet
Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet
Secondary Outcome Measures
Full Information
NCT ID
NCT02409784
First Posted
March 27, 2015
Last Updated
February 8, 2019
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT02409784
Brief Title
PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
Acronym
TEP-KD
Official Title
PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Brain metabolism, Ketones, Ketogenic diet, TEP scan
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Pre-KD
Intervention Description
Before starting 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Post-KD
Intervention Description
After 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet
Primary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen C Cunnane, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
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