Trial Outcomes & Findings for Brain Energy and Aging With Triheptanoin (NCT NCT02679235)
NCT ID: NCT02679235
Last Updated: 2020-07-23
Results Overview
Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
28±2 days
Results posted on
2020-07-23
Participant Flow
Participant milestones
| Measure |
Triheptanoin
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
Triheptanoin
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Overall Study
Withdrawal by Subject
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3
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Triheptanoin
n=11 Participants
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Age, Continuous
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69.9 years
STANDARD_DEVIATION 2.9 • n=11 Participants
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Sex: Female, Male
Female
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8 Participants
n=11 Participants
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Sex: Female, Male
Male
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3 Participants
n=11 Participants
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Glucose uptake changes estimated by comparing participants' measurements to imaging standards of hea
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-14.8 % of difference compare to young control
STANDARD_DEVIATION 3.9 • n=11 Participants
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Education
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16.5 years
STANDARD_DEVIATION 3.0 • n=11 Participants
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Montreal Cognitive Assessment (MoCA)
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27.3 scores on a scale
STANDARD_DEVIATION 2.6 • n=11 Participants
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body mass index
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26.4 kg/m^2
STANDARD_DEVIATION 5.2 • n=11 Participants
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PRIMARY outcome
Timeframe: 28±2 daysGlobal change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation
Outcome measures
| Measure |
Triheptanoin
n=11 Participants
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Global Change in Brain Glucose Uptake
PRE
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30.3 μmol/100 g/min
Standard Deviation 1.7
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Global Change in Brain Glucose Uptake
POST supplementation
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30.4 μmol/100 g/min
Standard Deviation 3.4
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PRIMARY outcome
Timeframe: 28±2 daysGlobal change in brain ketone uptake as measured by 11C-acetoacetate PET scans
Outcome measures
| Measure |
Triheptanoin
n=11 Participants
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Global Change in Brain Ketone Uptake
PRE
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0.58 μmol/100 g/min
Standard Deviation 0.4
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Global Change in Brain Ketone Uptake
POST supplementation
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0.26 μmol/100 g/min
Standard Deviation 0.2
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SECONDARY outcome
Timeframe: 28±2 daysPopulation: data was not available for 2 participants
Structural imaging by T1-weighted MRI to measure brain volume
Outcome measures
| Measure |
Triheptanoin
n=9 Participants
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Change in Brain Volumes
hipocampus PRE
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7.4 ml/100 g/ min
Standard Deviation 0.7
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Change in Brain Volumes
hipocampus POST supplementation
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7.4 ml/100 g/ min
Standard Deviation 0.7
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Change in Brain Volumes
Amygdala PRE
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3.0 ml/100 g/ min
Standard Deviation 0.5
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Change in Brain Volumes
Amygdala POST supplementation
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3.0 ml/100 g/ min
Standard Deviation 0.5
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Change in Brain Volumes
Thalamus PRE
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12.8 ml/100 g/ min
Standard Deviation 1.3
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Change in Brain Volumes
Thalamus POST suplementation
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12.5 ml/100 g/ min
Standard Deviation 1.2
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Change in Brain Volumes
Caudate PRE
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6.9 ml/100 g/ min
Standard Deviation 0.8
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Change in Brain Volumes
Caudate POST supplementation
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6.8 ml/100 g/ min
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: 28±2 dayschange in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex)
Outcome measures
| Measure |
Triheptanoin
n=11 Participants
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Change in Cerebral Blood Flow
PRE
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41.8 ml/100 g/ min
Standard Deviation 9.1
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Change in Cerebral Blood Flow
POST supplementation
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41.8 ml/100 g/ min
Standard Deviation 9.4
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Adverse Events
Triheptanoin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Triheptanoin
n=15 participants at risk
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.
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|---|---|
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Gastrointestinal disorders
severe stomach pain
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6.7%
1/15 • Number of events 1 • During 4 week supplementation period
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place