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

NCT02409784 | Completed Results

• 1 other identifier: 13-214
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Brain metabolism; Ketones; Ketogenic diet; TEP scan

Outcome Measures

Primary Outcomes (2)

• Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of 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

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

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

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; Dietary Supplement: Post-KD

Interventions

Pre-KD DIETARY_SUPPLEMENT

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

Ketogenic diet

Post-KD DIETARY_SUPPLEMENT

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

Ketogenic diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• No signs of cognitive impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pr. Stephen Cunnane
• Organization: Université de Sherbrooke

stephen.cunnane@usherbrooke.ca

819-780-2220

Study Officials

• Stephen C Cunnane, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 7, 2015
• Study Start: March 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 15, 2019
• Results First Posted: April 6, 2018

Record last verified: 2015-04