Brain Energy and Aging With Triheptanoin

Frontal Lobe Hypometabolism Clinical Trial

— BEAT7  

Official title:

Brain Energy and Aging With Triheptanoin: The BEAT7 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679235
• Other study ID #: 2016-617
• Secondary ID: 188505
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2016
• Est. completion date: August 8, 2018

Study information

• Verified date: July 2020
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 8, 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frontal Lobe Hypometabolism

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Fonds de la Recherche en Santé du Québec, Ultragenyx Pharmaceutical Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Change in Brain Glucose Uptake	Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation	28±2 days
Primary	Global Change in Brain Ketone Uptake	Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans	28±2 days
Secondary	Change in Brain Volumes	Structural imaging by T1-weighted MRI to measure brain volume	28±2 days
Secondary	Change in Cerebral Blood Flow	change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex)	28±2 days