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Brain Energy and Aging With Triheptanoin (BEAT7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679235
Recruitment Status : Completed
First Posted : February 10, 2016
Results First Posted : April 15, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
Ultragenyx Pharmaceutical Inc
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Université de Sherbrooke

Brief 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.

Condition or disease Intervention/treatment Phase
Frontal Lobe Hypometabolism Drug: POST Triheptanoin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The participant will receive THN treatment, compared to PRE supplementation condition.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brain Energy and Aging With Triheptanoin: The BEAT7 Study
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018

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 Name: POST THN




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679235


Locations
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Canada, Quebec
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, Canada, J1H4C4
Sponsors and Collaborators
Université de Sherbrooke
Ultragenyx Pharmaceutical Inc
Fonds de la Recherche en Santé du Québec
Investigators
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Principal Investigator: Stephen Cunnane, Ph.D. Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
  Study Documents (Full-Text)

Documents provided by Université de Sherbrooke:
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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02679235    
Other Study ID Numbers: 2016-617
188505 ( Registry Identifier: Office of Clinical Trials - Health Canada )
First Posted: February 10, 2016    Key Record Dates
Results First Posted: April 15, 2020
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No