Trial Outcomes & Findings for PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis (NCT NCT02409784)
NCT ID: NCT02409784
Last Updated: 2019-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet
Results posted on
2019-02-15
Participant Flow
Participant were recruited with advertising poster on bulletin board of different local organism (university, health clinic, sport and leisure association, etc)
Participant milestones
| Measure |
Ketogenic Diet
TEP study following a 4 day ketogenic diet (KD), consisting of a classic 4:1 KD (4:1 lipid to carbohydrate + protein ratio) in the form of liquid meal (water, cream, MCT oil, liquid egg white, flavor) and taken in 3 separates meal.
Intervention 1: Pre-KD = Participants did a TEP before starting the 4 days ketogenic diet
Intervention 2 : Post-KD = Participants did a TEP after the 4 days ketogenic diet
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis
Baseline characteristics by cohort
| Measure |
Ketogenic Diet
n=10 Participants
TEP study following a 4 day ketogenic diet (KD)
Intervention 1: Pre-KD = Participants did a TEP before starting a 4 days ketogenic diet Intervention 2: Post-KD = Participants did a TEP after 4 days of ketogenic diet
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic dietOutcome measures
| Measure |
Ketogenic Diet
n=10 Participants
TEP study with a 4 days ketogenic diet
Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet
Intervention 1: Pre-KD = Participants did a TEP before starting 4 days of ketogenic diet
Intervention 2: Post-KD = Participants did a TEP after 4 days of ketogenic diet
|
|---|---|
|
Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet
Pre-KD
|
0.672 µmol/100g/min
Standard Error 0.18
|
|
Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet
Post-KD
|
4.83 µmol/100g/min
Standard Error 0.75
|
PRIMARY outcome
Timeframe: At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic dietOutcome measures
| Measure |
Ketogenic Diet
n=10 Participants
TEP study with a 4 days ketogenic diet
Ketogenic diet: 4 days 4:1 (lipids:protein/carbohydrates) ketogenic diet
Intervention 1: Pre-KD = Participants did a TEP before starting 4 days of ketogenic diet
Intervention 2: Post-KD = Participants did a TEP after 4 days of ketogenic diet
|
|---|---|
|
Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet
Pre-KD
|
31.58 µmol/100g/min
Standard Error 3.02
|
|
Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet
Post-KD
|
24.46 µmol/100g/min
Standard Error 5.47
|
Adverse Events
Ketogenic Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place