Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT02654392
Status:
UNKNOWN
Last Update Posted:
2016-01-13
First Post:
2016-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
Sponsor:
University of Western Ontario, Canada
Organization:
Study Overview
Official Title:
Effect of Plant Omega-3 and Omega-6 Fatty Acids on Exercise Performance
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: