NCT02410161

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2013

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

March 16, 2015

Results QC Date

September 12, 2017

Last Update Submit

February 11, 2019

Conditions

Keywords

ketoneα-linolenic acidflaxseedagingβ-hydroxybutyrateacetoacetateomega-3 fatty acidsketogenesis

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

EXPERIMENTAL

Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks

Dietary Supplement: alpha-linolenic acid-rich supplement

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).

4 week ALA treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Ketosis

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Pr. Stephen Cunnane
Organization
Université de Sherbrooke

Study Officials

  • Stephen Cunnane, PhD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

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
Model Details: Dietary Supplement: alpha-linolenic acid-rich supplement
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