We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02654392
Recruitment Status : Unknown
Verified January 2016 by Peter Lemon, University of Western Ontario, Canada.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Peter Lemon, University of Western Ontario, Canada

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.

Condition or disease Intervention/treatment Phase
Effect of Essential Fatty Acids on Exercise Performance Dietary Supplement: corn syrup Dietary Supplement: Polyunsaturated fatty acid Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
Study Start Date : February 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Placebo Comparator: placebo
This group will receive isoenergetic carbohydrate (corn syrup) supplement daily for 5 weeks
Dietary Supplement: corn syrup
This group will receive an iso-energetic corn syrup supplement everyday for 5 weeks

Polyunsaturated fatty acid group
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)
Dietary Supplement: 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




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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.

  4. 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)


Secondary Outcome Measures :
  1. change in Body composition [ Time Frame: at baseline and 5 weeks after supplementation ]
    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

  2. change in Blood lactate [ Time Frame: at baseline and 5 weeks after supplementation ]
    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+).

  3. change in Blood glucose [ Time Frame: at baseline and 5 weeks after supplementation ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654392


Contacts
Layout table for location contacts
Contact: Peter Lemon, PhD 1 519 661 2111 ext 88139 plemon@uwo.ca
Contact: Victor Nguyen, BSc vnguye23@uwo.ca

Locations
Layout table for location information
Canada, Ontario
Exercise Nutrition Research Laboratory, Western University
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Layout table for investigator information
Principal Investigator: Peter Lemon, PhD Western University
Layout table for additonal information
Responsible Party: Peter Lemon, Professor & Weider Research Chair Director, Exercise Nutrition Research Laboratory, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT02654392    
Other Study ID Numbers: 10010467
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Lemon, University of Western Ontario, Canada:
Omega-3
Omega-6
Exercise Performance