Brain Energy and Aging With Triheptanoin (BEAT7)

Brain Energy and Aging With Triheptanoin: The BEAT7 Study

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.

Study Overview

• Status: Completed
• Conditions: Frontal Lobe Hypometabolism
• Intervention / Treatment: Drug: POST Triheptanoin

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H4C4
      • Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: POST THN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Global Change in Brain Ketone Uptake	Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans	28±2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brain Volumes	Structural imaging by T1-weighted MRI to measure brain volume	28±2 days
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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Ultragenyx Pharmaceutical Inc; Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Stephen Cunnane, Ph.D., Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 8, 2018
• Study Completion (Actual): August 8, 2018

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimate): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-617; 188505 (Registry Identifier: Office of Clinical Trials - Health Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO