- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02679235
Brain Energy and Aging With Triheptanoin (BEAT7)
July 7, 2020 updated by: Université de Sherbrooke
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Sherbrooke, Quebec, Canada, J1H4C4
- Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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28±2 days
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Global Change in Brain Ketone Uptake
Time Frame: 28±2 days
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Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans
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28±2 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Brain Volumes
Time Frame: 28±2 days
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Structural imaging by T1-weighted MRI to measure brain volume
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28±2 days
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Change in Cerebral Blood Flow
Time Frame: 28±2 days
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change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex)
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28±2 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Cunnane, Ph.D., Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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