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

NCT ID: NCT02409784

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pre-KD

Intervention Type: DIETARY_SUPPLEMENT

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

Post-KD

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Pre-KD

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

Intervention Type: DIETARY_SUPPLEMENT

Post-KD

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen C Cunnane, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Other Identifiers

13-214

Identifier Type: -

Identifier Source: org_study_id