Trial Outcomes & Findings for Effect of an Alpha-linolenic Acid-rich Supplement on Ketogenesis and Plasma Fatty Acids (NCT NCT02410161)

Results Overview

Total Ketone (acetoacetate + beta-hydroxybutyrate) concentration in plasma in average during the metabolic study day, measured hourly between 1 and 6h after breakfast

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

After 4 weeks

Results posted on

2019-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Young Group 4 Week ALA Treatment n=10 Participants 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).	Old Group 4 Week ALA Treatment n=10 Participants 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).	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	25 years STANDARD_DEVIATION 2.8 • n=5 Participants	73 years STANDARD_DEVIATION 7 • n=7 Participants	52 years STANDARD_DEVIATION 25 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Canada	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Young Group 4 Week ALA Treatment n=10 Participants 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).	Old Group 4 Week ALA Treatment n=10 Participants 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).
Ketone Production	217.71 µmol/L Standard Error 24	187.48 µmol/L Standard Error 17

SECONDARY outcome

Timeframe: After 4 weeks

Glucose measured in plasma in average during the metabolic study day, measure hourly between 0 and 6 h after breakfast

Outcome measures

Outcome measures
Measure	Young Group 4 Week ALA Treatment n=10 Participants 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).	Old Group 4 Week ALA Treatment n=10 Participants 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).
Plasma Glucose	4.75 mmol/L Standard Error 0.13	5.46 mmol/L Standard Error 0.19

SECONDARY outcome

Timeframe: After 4 weeks

Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast

Outcome measures

Outcome measures
Measure	Young Group 4 Week ALA Treatment n=10 Participants 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).	Old Group 4 Week ALA Treatment n=10 Participants 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).
Plasma Triglycerides	0.97 mmol/L Standard Error 0.15	1.81 mmol/L Standard Error 0.29

SECONDARY outcome

Timeframe: 4 weeks

Free fatty acids measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast

Outcome measures

Outcome measures
Measure	Young Group 4 Week ALA Treatment n=10 Participants 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).	Old Group 4 Week ALA Treatment n=10 Participants 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).
Plasma Free Fatty Acids	0.48 mmol/L Standard Error 0.05	0.55 mmol/L Standard Error 0.04

SECONDARY outcome

Timeframe: after 4 weeks

Insulin measured in plasma in average during the metabolic study day, measured hourly between 0 ans 6 h after breakfast

Outcome measures

Outcome measures
Measure	Young Group 4 Week ALA Treatment n=10 Participants 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).	Old Group 4 Week ALA Treatment n=10 Participants 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).
Insulin Concentration in Plasma	10.48 µIU/mL Standard Error 1.48	14.87 µIU/mL Standard Error 2.63

Adverse Events

Young Group 4 Week ALA Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Old Group 4 Week ALA Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr. Stephen Cunnane

Université de Sherbrooke

Phone: 819-780-2220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place