Clinical trial NCT02679235: Brain Energy and Aging With Triheptanoin
Official title: Brain Energy and Aging With Triheptanoin: The BEAT7 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Frontal Lobe Hypometabolism
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Ultragenyx Pharmaceutical Inc
name: Fonds de la Recherche en Santé du Québec
First posted: 2016-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participant will receive THN treatment, compared to PRE supplementation condition.
Primary purpose: TREATMENT

Brief 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 \<26/30 on the Montreal Cognitive Assessment;
* Medications likely to affect the primary cognitive outcome;
* Medical or psychiatric conditions that could interfere with study participation (Peterson et al. 2005);
* Fasting plasma glucose ≥7.0 mM (to avoid recruiting diabetics or pre-diabetics, both of which are risk factors for cognitive impairment in older persons (Mortimer et al. 2010) and also inhibit ketogenesis (Fukao et al. 2004);
* Clinically-significant gastro-intestinal disease/conditions;
* Clinically-significant liver disease/dysfunction : ALT ≥37 UI/L, AST ≥36 UI/L, Total bilirubin ≥26 μmol/L;
* Clinically-significant renal disease/dysfunction : creatinine ≥92 μmol/L, glomerular filtration rate \<60 ml/min/1.73 m2 or \>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.

Primary outcomes:
measure: Global Change in Brain Glucose Uptake
timeFrame: 28±2 days
measure: Global Change in Brain Ketone Uptake
timeFrame: 28±2 days
Secondary outcomes:
measure: Change in Brain Volumes
timeFrame: 28±2 days
measure: Change in Cerebral Blood Flow
timeFrame: 28±2 days
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
state: Quebec
Study officials:
affiliation: Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
name: Stephen Cunnane, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: