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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
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    June 28, 2017
    Last Updated
    June 29, 2017
    Sponsor
    Loughborough University
    Collaborators
    University of Worcester
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    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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