Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma Fatty Acids

February 11, 2019 updated by: Université de Sherbrooke

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged between 18 and 30 or 65 years and more

Exclusion Criteria:

  • 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

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4 week ALA treatment
Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks
Dietary supplement: alpha-linolenic acid-rich 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose
Time Frame: After 4 weeks
Glucose measured in plasma in average during the metabolic study day, measure hourly between 0 and 6 h after breakfast
After 4 weeks
Plasma Triglycerides
Time Frame: After 4 weeks
Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
After 4 weeks
Plasma Free Fatty Acids
Time Frame: 4 weeks
Free fatty acids measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
4 weeks
Insulin Concentration in Plasma
Time Frame: after 4 weeks
Insulin measured in plasma in average during the metabolic study day, measured hourly between 0 ans 6 h after breakfast
after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Stephen Cunnane, PhD, Université de Sherbrooke

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

July 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-389

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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