Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma Fatty Acids
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Background: As the main alternative fuel to glucose for the brain, increased plasma ketones could potentially help compensate for brain glucose hypometabolism occurring during aging. The precursor long-chain n-3 polyunsaturated fatty acid (PUFA), α-linolenic acid (ALA), is normally mostly β-oxidized and so could potentially be used to stimulate ketogenesis in humans. Objective: To compare the impact of an ALA-rich supplement on the ketogenic response in young and older healthy adults. Design: Ten young and ten older adults will consume a flaxseed oil supplement providing 2 g/d of ALA for 4 weeks. Plasma ketones, free fatty acids, triglycerides, glucose and insulin will be measured over 6 h during two metabolic study days, one before and one at the end of the supplementation. Hypothesis: ALA-rich supplement for 4 weeks will increase ketone production in both groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jul 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
April 7, 2015
CompletedResults Posted
Study results publicly available
February 18, 2019
CompletedFebruary 18, 2019
March 1, 2015
10 months
March 16, 2015
September 12, 2017
February 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ketone Production
Total Ketone (acetoacetate + beta-hydroxybutyrate) concentration in plasma in average during the metabolic study day, measured hourly between 1 and 6h after breakfast
After 4 weeks
Secondary Outcomes (4)
Plasma Glucose
After 4 weeks
Plasma Triglycerides
After 4 weeks
Plasma Free Fatty Acids
4 weeks
Insulin Concentration in Plasma
after 4 weeks
Study Arms (1)
4 week ALA treatment
EXPERIMENTALParticipants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks
Interventions
each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined).
Eligibility Criteria
You may qualify if:
- aged between 18 and 30 or 65 years and more
You may not qualify if:
- non smoker
- pregnancy or breastfeeding
- diabetes or insulin resistance
- uncontrolled thyroid disease, hepatic or renal disease
- uncontrolled high blood pressure
- medical treatment influencing lipid or glucide metabolism
- ongoing or past severe drug or alcohol abuse
- dementia or psychiatric difficulties or depression
- chronic immune condition or inflammation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pr. Stephen Cunnane
- Organization
- Université de Sherbrooke
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Cunnane, PhD
Université de Sherbrooke
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2015
First Posted
April 7, 2015
Study Start
July 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 18, 2019
Results First Posted
February 18, 2019
Record last verified: 2015-03