Exercise-induced InflammationNCT03205241
Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists
A study testing n-3 PUFA in people with Exercise-induced Inflammation, run by Loughborough University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Inflammation
- What is being tested?
- n-3 PUFA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- recreationally trained male cyclists
Who cannot join
- 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
About this study
Official title: 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.
Read more
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.
- Conditions
- Exercise-induced Inflammation
- Being tested
- n-3 PUFA, Placebo
- Keywords
- Exercise, Fish Oil, Cycling, Inflammation, Oxidative stress
- Medical subject headings
- Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 PUFADietary supplement
Also called Fish Oil supplementation, Omega-3
n-3 PUFA capsules containing EPA and DHA
PlaceboDietary supplement
Also called Olive Oil
Olive oil capsules
| Study group | Role | What they receive |
|---|---|---|
| n-3 PUFA | Experimental | Omega-3 polyunsaturated fatty acid - 5.7g/ day for 4 weeks Receives: Dietary Supplement: n-3 PUFA |
| Placebo | Placebo comparator | Olive Oil - 6g/ day for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Done
Work done measured in Joules from the Lode cycle ergometer during 15 minute cycling time trial
Measured: 15 minutes during time trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised, placebo-controlled, double blind, crossover design study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Worcester
- Responsible party
- Principal investigator, Lynsey Wilson, Loughborough University
- Investigators
- Lynsey S Wilson, MSc, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205241
- Sponsor's protocol ID
- R14-P72
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance or Oxidative and Inflammatory Parameters in Healthy Male Cyclists
- ClinicalTrials.gov ID
- NCT03205241
- Acronym / sponsor ID
- R14-P72
- Conditions
- Exercise-induced Inflammation
- Keywords
- Exercise, Fish Oil, Cycling, Inflammation, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University of Worcester
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, placebo-controlled, double blind, crossover design study
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFA | Experimental | Dietary Supplement: n-3 PUFAOmega-3 polyunsaturated fatty acid - 5.7g/ day for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOlive Oil - 6g/ day for 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- recreationally trained male cyclists
Key exclusion criteria (8 listed)
- History of coagulation/bleeding disorder
- History of metabolic disease
- Serious allergy
- History of heart disease
- Regular use of anti-inflammatory drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 PUFAAlso: Fish Oil supplementation, Omega-3n-3 PUFA capsules containing EPA and DHA | Dietary supplement | n-3 PUFA |
| PlaceboAlso: Olive OilOlive oil capsules | Dietary supplement | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynsey S Wilson, MSc principal investigator
Loughborough University
Questions about this trial
What is this clinical trial studying?
A study testing n-3 PUFA in people with Exercise-induced Inflammation, run by Loughborough University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Done (time frame: 15 minutes during time trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.