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OpenTrials
Completed

NCT Number: NCT02410161

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alpha-linolenic acid-rich supplement

Dietary 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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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. 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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma n-3 Polyunsaturated Fatty Acids in Young Compared to Older Adults

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 7, 2015
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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