Brain Energy and Aging With Triheptanoin

• Status: Completed
• Trial end date: 2018-08-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Université de Sherbrooke
• Collaborators: Fonds de la Recherche en Santé du Québec; Ultragenyx Pharmaceutical Inc

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.