An interventional study of alpha-linolenic acid-rich supplement in Healthy, sponsored by Université de Sherbrooke. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science
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.
195 studies on the registry are indexed under Ketosis; 41 are open to participants now.
This study's enrollment of 20 is below the median of 24 across 156 interventional studies indexed under Ketosis.
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Exclusion Criteria:
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).
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
Time frame: After 4 weeks
Plasma Glucose
Glucose measured in plasma in average during the metabolic study day, measure hourly between 0 and 6 h after breakfast
Time frame: After 4 weeks
Plasma Triglycerides
Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
Time frame: 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
Time frame: 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
Time frame: after 4 weeks
| Milestone | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Total Ketone (acetoacetate + beta-hydroxybutyrate) concentration in plasma in average during the metabolic study day, measured hourly between 1 and 6h after breakfast
| µmol/L | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment |
|---|---|---|
| Ketone Production | 217.71 ± 24 | 187.48 ± 17 |
Glucose measured in plasma in average during the metabolic study day, measure hourly between 0 and 6 h after breakfast
| mmol/L | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment |
|---|---|---|
| Plasma Glucose | 4.75 ± 0.13 | 5.46 ± 0.19 |
Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
| mmol/L | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment |
|---|---|---|
| Plasma Triglycerides | 0.97 ± 0.15 | 1.81 ± 0.29 |
Free fatty acids measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
| mmol/L | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment |
|---|---|---|
| Plasma Free Fatty Acids | 0.48 ± 0.05 | 0.55 ± 0.04 |
Insulin measured in plasma in average during the metabolic study day, measured hourly between 0 ans 6 h after breakfast
| µIU/mL | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment |
|---|---|---|
| Insulin Concentration in Plasma | 10.48 ± 1.48 | 14.87 ± 2.63 |
Collected over Adverse event were collected during the 4-weeks supplementation of each participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Young Group 4 Week ALA Treatment | — | 0/10 (0%) | 0/10 (0%) |
| Old Group 4 Week ALA Treatment | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 0 | 10 |
| >=65 years | 0 | 10 | 10 |
| Age, Continuous(years) | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment | Total |
|---|---|---|---|
| Mean | 25 ± 2.8 | 73 ± 7 | 52 ± 25 |
| Sex: Female, Male(Participants) | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 4 | 3 | 7 |
| Region of Enrollment(Participants) | Young Group 4 Week ALA Treatment | Old Group 4 Week ALA Treatment | Total |
|---|---|---|---|
| Canada | 10 | 10 | 20 |
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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