Effect of Essential Fatty Acids on Exercise PerformanceNCT02654392
Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
A study testing corn syrup and Polyunsaturated fatty acid in people with Effect of Essential Fatty Acids on Exercise Performance, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
Many studies in the past three decades have examined the beneficial effects of omega-3 polyunsaturated fatty acids in diet and supplementation. The effect of polyunsaturated fatty acids, specifically omega-3 and omega-6, on health have been well-studied but most of the study to date has been on animal not plant… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Essential Fatty Acids on Exercise Performance
- What is being tested?
- corn syrup and Polyunsaturated fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- Recreationally active (defined as those who attend a gym or play sports about 2-3 times a week),
- Non-pregnant student volunteers.
Who cannot join
- Participants cannot have taken omega-3 or other polyunsaturated fatty acid supplements or undergone any systematic exercise training in the past 3 months,
- Have symptoms or take medication for respiratory, cardiovascular, metabolic, or neuromuscular disease
- Injury limiting exercise ability
- Use heart rate or blood pressure medications
- Use any medications that have side effects for dizziness, lack of motor control, or slowed reaction time
- Smoker
Trial locations and contacts
1 site in 1 country.
Victor Nguyen, BSc contact
Canada1 site
Exercise Nutrition Research Laboratory, Western University
London, Ontario, N6A 3K7
About this study
Many studies in the past three decades have examined the beneficial effects of omega-3 polyunsaturated fatty acids in diet and supplementation. The effect of polyunsaturated fatty acids, specifically omega-3 and omega-6, on health have been well-studied but most of the study to date has been on animal not plant sources and much less is know about their effects on exercise performance. Additionally, while positive effects have been detected for sedentary populations or those that are at risk, well-trained athletes generally have not had established advantages in taking supplements for omega-3 and omega-6 oils. There is evidence that a specific ratio of omega-6 to omega-3 is most beneficial for the human body with regards to cardiovascular and mental health. In this study, participants randomized to either a plant supplement group (pureform omega; containing Flax, Evening Primrose, Sunflower, Coconut \& Pumpkin oils; Natural Product Number = 80050660) or placebo (isoenergetic sugar pills) will be subjected to both a time trial and a high intensity interval bout, where their performance and power output will be analyzed. Blood lactate and glucose concentration, as well as oxygen consumption and carbon dioxide production will also be examined to determine if there is a change in on fat oxidation after supplementation.
Read the detailed description
Double-blind placebo controlled study with two groups: a PUFA supplemented group (over 5 weeks) and a placebo (corn syrup) group. Participants are matched for initial exercise performance and assigned to each of the two groups systematically so the initial group means are similar. This is done by ranking all individuals from highest to lowest and assigning the participant with the highest score randomly to the treatment group and the other to the placebo group. Then, for the next two individuals in ranking, the highest of the two is assigned to the placebo group and the other to the treatment group. This procedure is repeated for all participant pairs. Of course, this is done separately for men and women because on average the men have greater exercise performance scores.
Dosage is 3.8 capsules/70kg body mass (rounded to the nearest capsule; 1 capsule contains 369mg PUFA from Flax, Evening Primrose, Pumpkin, Sunflower, and Coconut oil; <4 Calories) or isoenergetic placebo capsules (containing corn syrup) plus 2 capsules 20 minutes prior to exercise workouts. Eighteen recreationally active student volunteers (18-35 years old) will be recruited to complete 4 exercise tests: a cycle time trial (~15 minutes), a cycle maximal power test (30 second Wingate test), a maximal aerobic power test (running treadmill test) plus a strength/endurance test (number of bench presses with 60 kg load) pre- and post 5 weeks of daily supplementation. There will an accommodation day pre-study where each participant is familiarized with the tests to be used. Each exercise test will be completed on a separate day with at least 48 hours between each test day due to the fatiguing nature of the testing.
- Being tested
- corn syrup, Polyunsaturated fatty acid
- Keywords
- Omega-3, Omega-6, Exercise Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corn syrupDietary supplement
This group will receive an iso-energetic corn syrup supplement everyday for 5 weeks
Polyunsaturated fatty acidDietary supplement
This groups will receive 4 capsules/70kg body mass (Pureform Omega® capsules made from Fax, Sunflower, Coconut, Evening Primrose, \& Pumpkin oils) every day for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | This group will receive isoenergetic carbohydrate (corn syrup) supplement daily for 5 weeks Receives: Dietary Supplement: corn syrup |
| Polyunsaturated fatty acid group | Other | This group will receive a plant essential fatty acid food supplement, Pureform Omega® capsules made from Fax, Sunflower, Coconut, Evening Primrose, \& Pumpkin oils, containing a 2.5:1 omega-6 to omega-3 ratio (1.5 g per 70kg body mass plus an additional 0.5 g on exercise days) Receives: Dietary Supplement: Polyunsaturated fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cycle ergometer time trial
A 40 Km time trial test on a cycle ergometer will be conducted before and after a 5-week supplementation period
Measured: at baseline and 5 weeks after supplementation
change in Aerobic capacity (VO2 max) test
Aerobic capacity will be quantified using an incremental running test on a treadmill. The workload will be increased by increasing the slope (simulating a hill) at a constant speed (6mph)
Measured: at baseline and 5 weeks after supplementation
Change in Wingate Anaerobic Test
A 30 second intense effort on a cycle ergometer against a load equal to 9% of body mass. Peak power, mean power, total work and fatigue index will be recorded at the end of each sprint.
Measured: at baseline and 5 weeks after supplementation
change in Strength/Endurance test
Number of bench presses completed (rounded to the nearest 1/2 lift) with a 60 kg load and a metromone for pacing control (30 lifts per minute) will be used and rating of perceived exertion (RPE) will be assessed immediately before and immediately after each exercise test using the Borg Scale (analog scale with verbal identifiers)
Measured: at baseline and 5 weeks after supplementation
Secondary outcomes (3)
change in Body composition
Body composition will be measured by densitometry using air displacement plethysmography with a BodPod® (involves sitting comfortably in a chamber for about 2 minutes while the space the body takes up is measured) for the measurement of fat and fat-free mass
Measured: at baseline and 5 weeks after supplementation
change in Blood lactate
Capillary blood samples (0.6 microlitres) will be collected before and after each exercise session under standard sterile condition via standard skin prick technique for the measurement of blood lactate content using a blood lactate analyzer (Lactate Scout+).
Measured: at baseline and 5 weeks after supplementation
change in Blood glucose
Capillary blood samples (0.6 microlitres) will be collected before and after each exercise session under standard sterile condition via standard skin prick technique for the measurement of blood glucose content using a blood glucose analyzer (Free Style Lite)
Measured: at baseline and 5 weeks after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Essential Fatty Acids on Exercise PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, University of Western Ontario, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654392
- Sponsor's protocol ID
- 10010467
- Status last verified
- Jan 2016
- First submitted
- 9 Jan 2016
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
- ClinicalTrials.gov ID
- NCT02654392
- Acronym / sponsor ID
- 10010467
- Keywords
- Omega-3, Omega-6, Exercise Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many studies in the past three decades have examined the beneficial effects of omega-3 polyunsaturated fatty acids in diet and supplementation. The effect of polyunsaturated fatty acids, specifically omega-3 and omega-6, on health have been well-studied but most of the study to date has been on animal not plant sources and much less is know about their effects on exercise performance. Additionally, while positive effects have been detected for sedentary populations or those that are at risk, well-trained athletes generally have not had established advantages in taking supplements for omega-3 and omega-6 oils. There is evidence that a specific ratio of omega-6 to omega-3 is most beneficial for the human body with regards to cardiovascular and mental health. In this study, participants randomized to either a plant supplement group (pureform omega; containing Flax, Evening Primrose, Sunflower, Coconut \& Pumpkin oils; Natural Product Number = 80050660) or placebo (isoenergetic sugar pills) will be subjected to both a time trial and a high intensity interval bout, where their performance and power output will be analyzed. Blood lactate and glucose concentration, as well as oxygen consumption and carbon dioxide production will also be examined to determine if there is a change in on fat oxidation after supplementation.
Detailed description
Double-blind placebo controlled study with two groups: a PUFA supplemented group (over 5 weeks) and a placebo (corn syrup) group. Participants are matched for initial exercise performance and assigned to each of the two groups systematically so the initial group means are similar. This is done by ranking all individuals from highest to lowest and assigning the participant with the highest score randomly to the treatment group and the other to the placebo group. Then, for the next two individuals in ranking, the highest of the two is assigned to the placebo group and the other to the treatment group. This procedure is repeated for all participant pairs. Of course, this is done separately for men and women because on average the men have greater exercise performance scores.
Dosage is 3.8 capsules/70kg body mass (rounded to the nearest capsule; 1 capsule contains 369mg PUFA from Flax, Evening Primrose, Pumpkin, Sunflower, and Coconut oil; <4 Calories) or isoenergetic placebo capsules (containing corn syrup) plus 2 capsules 20 minutes prior to exercise workouts. Eighteen recreationally active student volunteers (18-35 years old) will be recruited to complete 4 exercise tests: a cycle time trial (~15 minutes), a cycle maximal power test (30 second Wingate test), a maximal aerobic power test (running treadmill test) plus a strength/endurance test (number of bench presses with 60 kg load) pre- and post 5 weeks of daily supplementation. There will an accommodation day pre-study where each participant is familiarized with the tests to be used. Each exercise test will be completed on a separate day with at least 48 hours between each test day due to the fatiguing nature of the testing.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: corn syrupThis group will receive isoenergetic carbohydrate (corn syrup) supplement daily for 5 weeks |
| Polyunsaturated fatty acid group | Other | Dietary Supplement: Polyunsaturated fatty acidThis group will receive a plant essential fatty acid food supplement, Pureform Omega® capsules made from Fax, Sunflower, Coconut, Evening Primrose, \& Pumpkin oils, containing a 2.5:1 omega-6 to omega-3 ratio (1.5 g per 70kg body mass plus an additional 0.5 g on exercise days) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy,
- Recreationally active (defined as those who attend a gym or play sports about 2-3 times a week),
- Non-pregnant student volunteers.
Key exclusion criteria (6 listed)
- Participants cannot have taken omega-3 or other polyunsaturated fatty acid supplements or undergone any systematic exercise training in the past 3 months,
- Have symptoms or take medication for respiratory, cardiovascular, metabolic, or neuromuscular disease
- Injury limiting exercise ability
- Use heart rate or blood pressure medications
- Use any medications that have side effects for dizziness, lack of motor control, or slowed reaction time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corn syrupThis group will receive an iso-energetic corn syrup supplement everyday for 5 weeks | Dietary supplement | placebo |
| Polyunsaturated fatty acidThis groups will receive 4 capsules/70kg body mass (Pureform Omega® capsules made from Fax, Sunflower, Coconut, Evening Primrose, \& Pumpkin oils) every day for 5 weeks | Dietary supplement | Polyunsaturated fatty acid group |
Primary outcome
change in cycle ergometer time trial
Time frame: at baseline and 5 weeks after supplementation
A 40 Km time trial test on a cycle ergometer will be conducted before and after a 5-week supplementation period
change in Aerobic capacity (VO2 max) test
Time frame: at baseline and 5 weeks after supplementation
Aerobic capacity will be quantified using an incremental running test on a treadmill. The workload will be increased by increasing the slope (simulating a hill) at a constant speed (6mph)
Change in Wingate Anaerobic Test
Time frame: at baseline and 5 weeks after supplementation
A 30 second intense effort on a cycle ergometer against a load equal to 9% of body mass. Peak power, mean power, total work and fatigue index will be recorded at the end of each sprint.
change in Strength/Endurance test
Time frame: at baseline and 5 weeks after supplementation
Number of bench presses completed (rounded to the nearest 1/2 lift) with a 60 kg load and a metromone for pacing control (30 lifts per minute) will be used and rating of perceived exertion (RPE) will be assessed immediately before and immediately after each exercise test using the Borg Scale (analog scale with verbal identifiers)
3 secondary outcomes
change in Body composition
Time frame: at baseline and 5 weeks after supplementation
change in Blood lactate
Time frame: at baseline and 5 weeks after supplementation
change in Blood glucose
Time frame: at baseline and 5 weeks after supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Nguyen, BSc contact
Peter Lemon, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corn syrup and Polyunsaturated fatty acid in people with Effect of Essential Fatty Acids on Exercise Performance, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Lemon, PhD (1 519 661 2111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in cycle ergometer time trial (time frame: at baseline and 5 weeks after supplementation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.