Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists

June 29, 2017 updated by: Lynsey Wilson, Loughborough University

Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance or Oxidative and Inflammatory Parameters in Healthy Male Cyclists

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

  1. Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following high intensity cycling.
  2. Is a modulation of the inflammatory response connected to cycling performance.

Hypotheses

  1. Four weeks of n3-PUFA supplementation will reduce the inflammatory response
  2. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: n-3 PUFA
Omega-3 polyunsaturated fatty acid - 5.7g/ day for 4 weeks
Dietary supplement: n-3 PUFA
n-3 PUFA capsules containing EPA and DHA
Other Names:
  • Omega-3
  • Fish Oil supplementation
PLACEBO_COMPARATOR: Placebo
Olive Oil - 6g/ day for 4 weeks
Dietary supplement: Placebo
Olive oil capsules
Other Names:
  • Olive Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work Done
Time Frame: 15 minutes during time trial
Work done measured in Joules from the Lode cycle ergometer during 15 minute cycling time trial
15 minutes during time trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loughborough University

Collaborators

University of Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R14-P72

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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