NCT03205241

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

  1. 1.Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following high intensity cycling.
  2. 2.Is a modulation of the inflammatory response connected to cycling performance.
  3. 3.Four weeks of n3-PUFA supplementation will reduce the inflammatory response
  4. 4.A reduction in inflammation will improve cycling performance

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

June 28, 2017

Last Update Submit

June 29, 2017

Conditions

Keywords

ExerciseFish OilCyclingInflammationOxidative stress

Outcome Measures

Primary Outcomes (1)

  • Work Done

    Work done measured in Joules from the Lode cycle ergometer during 15 minute cycling time trial

    15 minutes during time trial

Study Arms (2)

n-3 PUFA

EXPERIMENTAL

Omega-3 polyunsaturated fatty acid - 5.7g/ day for 4 weeks

Dietary Supplement: n-3 PUFA

Placebo

PLACEBO COMPARATOR

Olive Oil - 6g/ day for 4 weeks

Dietary Supplement: Placebo

Interventions

n-3 PUFADIETARY_SUPPLEMENT

n-3 PUFA capsules containing EPA and DHA

Also known as: Fish Oil supplementation, Omega-3
n-3 PUFA
PlaceboDIETARY_SUPPLEMENT

Olive oil capsules

Also known as: Olive Oil
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • recreationally trained male cyclists

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivityInflammation

Interventions

Fatty Acids, Omega-3Docosahexaenoic AcidsOlive Oil

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Lynsey S Wilson, MSc

    Loughborough University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomised, placebo-controlled, double blind, crossover design study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Technical Tutor in Exercise Physiology

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share