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Completed

NCT Number: NCT02679235

Brain Energy and Aging With Triheptanoin

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Sherbrooke, Quebec, J1H4C4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

POST Triheptanoin

Drug

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

Primary outcomes

  1. Global Change in Brain Glucose Uptake

    Time frame: 28±2 days

    Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation

  2. Global Change in Brain Ketone Uptake

    Time frame: 28±2 days

    Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans

Secondary outcomes

  1. Change in Brain Volumes

    Time frame: 28±2 days

    Structural imaging by T1-weighted MRI to measure brain volume

  2. Change in Cerebral Blood Flow

    Time frame: 28±2 days

    change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec
  • Ultragenyx Pharmaceutical Inc

Registry information

Official study title

Brain Energy and Aging With Triheptanoin: The BEAT7 Study

Acronym: BEAT7

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 10, 2016
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.