Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists
Primary Purpose
Exercise-induced Inflammation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
n-3 PUFA
Placebo
Sponsored by

About this trial
This is an interventional basic science trial for Exercise-induced Inflammation focused on measuring Exercise, Fish Oil, Cycling, Inflammation, Oxidative stress
Eligibility Criteria
Inclusion Criteria:
- recreationally trained male cyclists
Exclusion Criteria:
- History of coagulation/bleeding disorder
- History of metabolic disease
- Serious allergy
- History of heart disease
- Regular use of anti-inflammatory drugs
- Vitamin or fish oil supplementation over the past 6 months
- Known to have blood-borne virus
- Females
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
n-3 PUFA
Placebo
Arm Description
Omega-3 polyunsaturated fatty acid - 5.7g/ day for 4 weeks
Olive Oil - 6g/ day for 4 weeks
Outcomes
Primary Outcome Measures
Work Done
Work done measured in Joules from the Lode cycle ergometer during 15 minute cycling time trial
Secondary Outcome Measures
Full Information
NCT ID
NCT03205241
First Posted
June 28, 2017
Last Updated
June 29, 2017
Sponsor
Loughborough University
Collaborators
University of Worcester
1. Study Identification
Unique Protocol Identification Number
NCT03205241
Brief Title
Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists
Official Title
Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance or Oxidative and Inflammatory Parameters in Healthy Male Cyclists
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
University of Worcester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Research Plan
Eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout between supplementation periods. During the performance trials blood, expired air and heart rate were collected. The blood samples have been used to investigate the production of inflammation resulting from the cycling performance test. Inflammation has been assessed using enzyme-linked immunosorbent assay for IL-6, which is an inflammatory cytokine. Work done from the cycling performance will be analysed to investigate whether there is a relationship with power and inflammation and whether this is modulated by fish oil supplementation.
Specific Aims
Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following high intensity cycling.
Is a modulation of the inflammatory response connected to cycling performance.
Hypotheses
Four weeks of n3-PUFA supplementation will reduce the inflammatory response
A reduction in inflammation will improve cycling performance
Anticipated Outcomes
A high level of cycling performance, indicated by a high average power, will be associated with high levels of systemic inflammation. n3-PUFA supplementation will decrease the level of inflammation and consequently cycling performance will be improved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Inflammation
Keywords
Exercise, Fish Oil, Cycling, Inflammation, Oxidative stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised, placebo-controlled, double blind, crossover design study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
n-3 PUFA
Arm Type
Experimental
Arm Description
Omega-3 polyunsaturated fatty acid - 5.7g/ day for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Olive Oil - 6g/ day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 PUFA
Other Intervention Name(s)
Fish Oil supplementation, Omega-3
Intervention Description
n-3 PUFA capsules containing EPA and DHA
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Olive Oil
Intervention Description
Olive oil capsules
Primary Outcome Measure Information:
Title
Work Done
Description
Work done measured in Joules from the Lode cycle ergometer during 15 minute cycling time trial
Time Frame
15 minutes during time trial
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
recreationally trained male cyclists
Exclusion Criteria:
History of coagulation/bleeding disorder
History of metabolic disease
Serious allergy
History of heart disease
Regular use of anti-inflammatory drugs
Vitamin or fish oil supplementation over the past 6 months
Known to have blood-borne virus
Females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynsey S Wilson, MSc
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists
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