- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02654392
Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Exercise Nutrition Research Laboratory, Western University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
This group will receive isoenergetic carbohydrate (corn syrup) supplement daily for 5 weeks
|
This group will receive an iso-energetic corn syrup supplement everyday for 5 weeks
|
|
Other: 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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at baseline and 5 weeks after supplementation
|
|
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)
|
at baseline and 5 weeks after supplementation
|
|
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.
|
at baseline and 5 weeks after supplementation
|
|
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)
|
at baseline and 5 weeks after supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at baseline and 5 weeks after supplementation
|
|
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+).
|
at baseline and 5 weeks after supplementation
|
|
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)
|
at baseline and 5 weeks after supplementation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10010467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Effect of Essential Fatty Acids on Exercise Performance
-
University of North Carolina, Chapel HillCompletedEffect of Fatty Acids on Memory Performance of ToddlersUnited States
-
Gdansk University of Physical Education and SportUniversity of Southampton; Medical University of GdanskCompletedEffect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue FunctionsPoland
-
University of South BohemiaCompletedEffect of Supplementation on PerformanceCzechia
-
University of Western Ontario, CanadaUnknownEffect of Superstarch on Soccer Performance
-
University of Central FloridaGencor Pacific GroupRecruitingEffect of Resveratrol on Performance and RecoveryUnited States
-
Washington University School of MedicineSt. Louis Jewish Community Center; St. Louis Naturally Occurring Retirement...CompletedEffect of Exercise on Cognitive FunctionUnited States
-
Synapse bvMaastricht UniversityCompletedThe Effect of Strenuous Exercise on Haemostasis.Netherlands
-
Mersin UniversityCompletedThe Effects of Neuromuscular Electrical Stimulation on Exercise PerformanceTurkey
-
Simon Fraser UniversityForm Athletica Inc.CompletedEffect of Real-time Visual Feedback on Participant Compliance, Motivation, and Performance in SwimmingCanada
-
University of BolognaCompletedEffect of Different Exercise Programs on Body CompositionItaly
Clinical Trials on corn syrup
-
Washington University School of MedicineCompleted
-
John SievenpiperCanadian Diabetes Association; The Physicians' Services Incorporated Foundation and other collaboratorsUnknownObesity | Overweight | Body Weight | Adiposity | Obesity, AbdominalCanada
-
University of TorontoCanadian Institutes of Health Research (CIHR); Canadian Diabetes Association; The Physicians' Services Incorporated FoundationUnknownCardiovascular Diseases | Stroke | Hypertension | Diabetes Mellitus, Type 2 | Gout | Metabolic Syndrome XCanada
-
University of California, DavisNational Heart, Lung, and Blood Institute (NHLBI); University of Southern California and other collaboratorsCompletedObesity | Type 2 Diabetes | Chronic Disease of Cardiovascular SystemUnited States
-
University of TorontoCompletedAbdominal ObesityCanada
-
University of TorontoCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated... and other collaboratorsUnknownHypertension | Obesity | Cardiovascular Disease | Dyslipidemia | Prediabetes | Gout | Non-Alcoholic Fatty Liver Disease | DysglycemiaCanada
-
Fred Hutchinson Cancer CenterNational Heart, Lung, and Blood Institute (NHLBI); University of WashingtonCompletedObesity | Cardiovascular Disease | Type 2 Diabetes Mellitus | Intestinal Permeability | Low-grade Chronic InflammationUnited States
-
University of British ColumbiaCompletedFocus of Study: Oral Tolerance Test With Glucose, Lactose, SucroseCanada
-
UCSF Benioff Children's Hospital OaklandAlmond Board of CaliforniaCompleted