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Trial record 6 of 17 for:    linoleic | linolenic acid

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

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ClinicalTrials.gov Identifier: NCT02410161
Recruitment Status : Completed
First Posted : April 7, 2015
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Intervention Dietary Supplement: alpha-linolenic acid-rich supplement
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Hide Arm/Group Description

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).

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).

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
0
   0.0%
10
  50.0%
>=65 years
0
   0.0%
10
 100.0%
10
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
25  (2.8) 73  (7) 52  (25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
7
  70.0%
13
  65.0%
Male
4
  40.0%
3
  30.0%
7
  35.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 10 participants 10 participants 20 participants
10
 100.0%
10
 100.0%
20
 100.0%
1.Primary Outcome
Title Ketone Production
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: µmol/L
217.71  (24) 187.48  (17)
2.Secondary Outcome
Title Plasma Glucose
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: mmol/L
4.75  (0.13) 5.46  (0.19)
3.Secondary Outcome
Title Plasma Triglycerides
Hide Description Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast
Time Frame After 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: mmol/L
0.97  (0.15) 1.81  (0.29)
4.Secondary Outcome
Title Plasma Free Fatty Acids
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: mmol/L
0.48  (0.05) 0.55  (0.04)
5.Secondary Outcome
Title Insulin Concentration in Plasma
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: µIU/mL
10.48  (1.48) 14.87  (2.63)
Time Frame Adverse event were collected during the 4-weeks supplementation of each participant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Hide Arm/Group Description

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).

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).

All-Cause Mortality
Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Young Group 4 Week ALA Treatment Old Group 4 Week ALA Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pr. Stephen Cunnane
Organization: Université de Sherbrooke
Phone: 819-780-2220 ext 45670
EMail: stephen.cunnane@usherbrooke.ca
Layout table for additonal information
Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02410161     History of Changes
Other Study ID Numbers: 2014-389
First Submitted: March 16, 2015
First Posted: April 7, 2015
Results First Submitted: September 12, 2017
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019