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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
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Brain metabolism, Ketones, Ketogenic diet, TEP scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 27, 2015
    Last Updated
    February 8, 2019
    Sponsor
    Université de Sherbrooke
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    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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