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

February 8, 2019 updated by: Université de Sherbrooke
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic diet

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
Dietary supplement: Pre-KD
Before starting 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet
Dietary supplement: Post-KD
After 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Stephen C Cunnane, PhD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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