Clinical trial NCT02654392: Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
Official title: Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effect of Essential Fatty Acids on Exercise Performance
Keywords: Omega-3
Omega-6
Exercise Performance
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Healthy,
* Recreationally active (defined as those who attend a gym or play sports about 2-3 times a week),
* Non-pregnant student volunteers.

Exclusion Criteria:

* 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

Primary outcomes:
measure: change in cycle ergometer time trial
timeFrame: at baseline and 5 weeks after supplementation
measure: change in Aerobic capacity (VO2 max) test
timeFrame: at baseline and 5 weeks after supplementation
measure: Change in Wingate Anaerobic Test
timeFrame: at baseline and 5 weeks after supplementation
measure: change in Strength/Endurance test
timeFrame: at baseline and 5 weeks after supplementation
Secondary outcomes:
measure: change in Body composition
timeFrame: at baseline and 5 weeks after supplementation
measure: change in Blood lactate
timeFrame: at baseline and 5 weeks after supplementation
measure: change in Blood glucose
timeFrame: at baseline and 5 weeks after supplementation
Other outcomes:
Locations:
city: London
country: Canada
facility: Exercise Nutrition Research Laboratory, Western University
state: Ontario
Study officials:
affiliation: Western University
name: Peter Lemon, PhD
role: PRINCIPAL_INVESTIGATOR
References: