HealthyNCT02410161
Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma Fatty Acids
A study testing alpha-linolenic acid-rich supplement in people with Healthy, run by Université de Sherbrooke.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- alpha-linolenic acid-rich supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 18 and 30 or 65 years and more
Who cannot join
- 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
Show all 9Show fewer
- ongoing or past severe drug or alcohol abuse
- dementia or psychiatric difficulties or depression
- chronic immune condition or inflammation
About this study
Official title: Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma n-3 Polyunsaturated Fatty Acids in Young Compared to Older Adults
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.
Read more
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.
- Conditions
- Healthy
- Being tested
- alpha-linolenic acid-rich supplement
- Keywords
- ketone, α-linolenic acid, flaxseed, aging, β-hydroxybutyrate, acetoacetate, omega-3 fatty acids, ketogenesis
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha-linolenic acid-rich supplementDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| 4 week ALA treatment | Experimental | Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks Receives: Dietary Supplement: alpha-linolenic acid-rich supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 4 weeks
Secondary outcomes (4)
Plasma Glucose
Glucose measured in plasma in average during the metabolic study day, measure hourly between 0 and 6 h after breakfast
Measured: After 4 weeks
Plasma Triglycerides
Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
Measured: After 4 weeks
Plasma Free Fatty Acids
Free fatty acids measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
Measured: 4 weeks
Insulin Concentration in Plasma
Insulin measured in plasma in average during the metabolic study day, measured hourly between 0 ans 6 h after breakfast
Measured: after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dietary Supplement: alpha-linolenic acid-rich supplement
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Cunnane, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410161
- Sponsor's protocol ID
- 2014-389
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma n-3 Polyunsaturated Fatty Acids in Young Compared to Older Adults
- ClinicalTrials.gov ID
- NCT02410161
- Acronym / sponsor ID
- 2014-389
- Conditions
- Healthy
- Keywords
- ketone, α-linolenic acid, flaxseed, aging, β-hydroxybutyrate, acetoacetate, omega-3 fatty acids, ketogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dietary Supplement: alpha-linolenic acid-rich supplement
| Arm | Type | Receives |
|---|---|---|
| 4 week ALA treatment | Experimental | Dietary Supplement: alpha-linolenic acid-rich supplementParticipants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 18 and 30 or 65 years and more
Key exclusion criteria (9 listed)
- non smoker
- pregnancy or breastfeeding
- diabetes or insulin resistance
- uncontrolled thyroid disease, hepatic or renal disease
- uncontrolled high blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alpha-linolenic acid-rich supplementeach 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). | Dietary supplement | 4 week ALA treatment |
Primary outcome
Ketone Production
Time frame: After 4 weeks
Total Ketone (acetoacetate + beta-hydroxybutyrate) concentration in plasma in average during the metabolic study day, measured hourly between 1 and 6h after breakfast
4 secondary outcomes
Plasma Glucose
Time frame: After 4 weeks
Plasma Triglycerides
Time frame: After 4 weeks
Plasma Free Fatty Acids
Time frame: 4 weeks
Insulin Concentration in Plasma
Time frame: after 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Cunnane, PhD principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
A study testing alpha-linolenic acid-rich supplement in people with Healthy, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ketone Production (time frame: After 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.