Phase 2
N=15
Brain Energy and Aging With Triheptanoin
Frontal Lobe Hypometabolism
Bottom Line
View on ClinicalTrials.gov: NCT02679235 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Global Change in Brain Glucose Uptake — 30.3; 30.4 μmol/100 g/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- POST Triheptanoin (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Université de Sherbrooke
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Change in Brain Glucose Uptake |
30.3; 30.4 | — |
| PRIMARY Global Change in Brain Ketone Uptake |
0.58; 0.26 | — |
| SECONDARY Change in Brain Volumes |
7.4; 7.4; 3.0; 3.0; 12.8; 12.5 | — |
| SECONDARY Change in Cerebral Blood Flow |
41.8; 41.8 | — |
Summary
BEAT7-001 is a single group study (supplementation). Using a multi-modal brain imaging portfolio, this study will assess whether brain energy metabolism (glucose and ketones), structure or functional connectivity change in older people with frontal glucose hypometabolism after 28 days on an oral dose of 1 g/kg/day of triheptanoin.
Eligibility Criteria
Inclusion Criteria
- Men and women ≥65 years old;
- Score ≥26/30 on the Montreal Cognitive Assessment; -≥10% lower brain glucose uptake in the frontal cortex as determined by PET imaging.
Exclusion Criteria
- Score 90 ml/min/1.73 m2;
- Clinically-significant cardiac disease/conditions;
- Clinically-significant abnormal coagulation laboratory results or coagulation disorders at screening;
- Poorly controlled dyslipidemia (total cholesterol ≥6.2 mmol/L or triglycerides ≥2.20 mmol/L)
- Hypertension: ≥140/90 mmHg;
- Substance abuse;
- Already on MCT supplementation;
- Visual or hearing impairment impeding comprehension;
- Non-French speaking;
- Any condition with life expectancy less than 5 years;
- Institutionalized or intending to move out of area within 1 year;
- Participation in other intervention trials.
Data sourced from ClinicalTrials.gov (NCT02679235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.