Brain Energy and Aging With Triheptanoin (BEAT7)

Université de Sherbrooke

Status and phase: Completed; Phase 2; Phase 1

Conditions: Frontal Lobe Hypometabolism

Treatments: Drug: POST Triheptanoin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02679235

188505 (Registry Identifier)

2016-617

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Triheptanoin

Experimental group

Description:

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.

Treatment:

Drug: POST Triheptanoin