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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02654392
Other study ID # 10010467
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 9, 2016
Last updated January 12, 2016
Start date February 2016
Est. completion date February 2017

Study information

Verified date January 2016
Source University of Western Ontario, Canada
Contact Peter Lemon, PhD
Phone 1 519 661 2111
Email plemon@uwo.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms

  • Effect of Essential Fatty Acids on Exercise Performance

Intervention

Dietary Supplement:
corn syrup
This group will receive an iso-energetic corn syrup supplement everyday for 5 weeks
Polyunsaturated fatty acid
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

Locations

Country Name City State
Canada Exercise Nutrition Research Laboratory, Western University London Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at baseline and 5 weeks after supplementation No
Primary 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) at baseline and 5 weeks after supplementation No
Primary 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. at baseline and 5 weeks after supplementation No
Primary 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) at baseline and 5 weeks after supplementation No
Secondary 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 at baseline and 5 weeks after supplementation No
Secondary 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+). at baseline and 5 weeks after supplementation No
Secondary 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) at baseline and 5 weeks after supplementation No