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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 week ALA treatment | Experimental | Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose | 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 | Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Cunnane, PhD | Université de Sherbrooke | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Young Group 4 Week ALA Treatment | Participants will receive the alpha-linolenic acid-rich supplement (ALA) (1000mg 4 times par day) for 4 weeks 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). |
| FG001 | Old Group 4 Week ALA Treatment | Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Young Group 4 Week ALA Treatment | Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | µmol/L | After 4 weeks |
|
Adverse event were collected during the 4-weeks supplementation of each participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Young Group 4 Week ALA Treatment | Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Stephen Cunnane | Université de Sherbrooke | 819-780-2220 | 45670 | stephen.cunnane@usherbrooke.ca |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Dietary Supplement: alpha-linolenic acid-rich supplement
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|
| 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 | 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 | after 4 weeks |
| BG001 | Old Group 4 Week ALA Treatment | Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Old Group 4 Week ALA Treatment |
Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks 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). |
|
|
| Secondary | Plasma Glucose | Glucose measured in plasma in average during the metabolic study day, measure hourly between 0 and 6 h after breakfast | Posted | Mean | Standard Error | mmol/L | After 4 weeks |
|
|
|
| Secondary | Plasma Triglycerides | Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast | Posted | Mean | Standard Error | mmol/L | After 4 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Error | mmol/L | 4 weeks |
|
|
|
| Secondary | Insulin Concentration in Plasma | Insulin measured in plasma in average during the metabolic study day, measured hourly between 0 ans 6 h after breakfast | Posted | Mean | Standard Error | µIU/mL | after 4 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Old Group 4 Week ALA Treatment | Participants will receive the alpha-linolenic acid-rich supplement (1000mg 4 times par day) for 4 weeks 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). | 0 | 10 | 0 | 10 |
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