Exercise-induced InflammationFATNCT03259412
Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance
A study testing Fish Oil in people with Exercise-induced Inflammation, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The aim of the study is to determine whether fish oil (specifically omega-3 long chain polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance exercise performance when combined with a resistance exercise training study. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Inflammation
- What is being tested?
- Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2016to 20 Dec 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- Healthy
Who cannot join
- Resistance exercise training within the past 6 months
- Vitamin or fish oil supplementation over the past 6 months
- Habitual use of anti-inflammatory drugs
- History of heart disease
- History of coagulation/bleeding disorder
- History of metabolic disease
Show all 10Show fewer
- Serious allergy
- Known to have blood-borne virus
- Females (Due to differences in cell membrane incorporation of Omega-3 between the sexes and the testing schedule being unable to fit in with menstrual cycle, altering the blood markers that are being measured)
- Currently no symptoms of general illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance, Inflammation, Gene Expression and Epigenetic Signatures
The aim of the study is to determine whether fish oil (specifically omega-3 long chain polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance exercise performance when combined with a resistance exercise training study. The investigators aim to establish the potential mechanisms that might mediate performance changes at a cellular level.
- Conditions
- Exercise-induced Inflammation
- Being tested
- Fish Oil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Also called n-3 PUFA, Omega-3
Fish Oil Capsule
PlaceboDietary supplement
Also called Olive Oil
Olive Oil capsule manufactured to mimic fish oil capsule
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | Fish oil 5.1g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway Receives: Dietary Supplement: Fish Oil |
| Placebo | Placebo comparator | Olive Oil 6g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Quadriceps and Hamstring strength using an isokinetic dynamometer
Measured: Change from baseline strength at 11 weeks
Leg power
Dynamic leg power assessed through jump height on force platform
Measured: Change from baseline strength at 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Jan 2016
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynsey Wilson, Loughborough University
- Investigators
- Lynsey S Wilson, MSc, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259412
- Sponsor's protocol ID
- LoughboroughU
- Acronym
- FAT
- Status last verified
- Mar 2018
- First submitted
- 4 Aug 2017
- Last updated
- 27 Mar 2018
- 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 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance, Inflammation, Gene Expression and Epigenetic Signatures
- ClinicalTrials.gov ID
- NCT03259412
- Acronym / sponsor ID
- FAT / LoughboroughU
- Conditions
- Exercise-induced Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 23 Aug 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.
The aim of the study is to determine whether fish oil (specifically omega-3 long chain polyunsaturated fatty acids [EPA-DHA]) supplementation can enhance eccentric resistance exercise performance when combined with a resistance exercise training study. The investigators aim to establish the potential mechanisms that might mediate performance changes at a cellular level.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Dietary Supplement: Fish OilFish oil 5.1g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOlive Oil 6g/ day - Premium Omega-3, Norwegian Pure-3, Oslo, Norway |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males
- Healthy
Key exclusion criteria (10 listed)
- Resistance exercise training within the past 6 months
- Vitamin or fish oil supplementation over the past 6 months
- Habitual use of anti-inflammatory drugs
- History of heart disease
- History of coagulation/bleeding disorder
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 |
|---|---|---|
| Fish OilAlso: n-3 PUFA, Omega-3Fish Oil Capsule | Dietary supplement | Fish Oil |
| PlaceboAlso: Olive OilOlive Oil capsule manufactured to mimic fish oil capsule | Dietary supplement | Placebo |
Primary outcome
Strength
Time frame: Change from baseline strength at 11 weeks
Quadriceps and Hamstring strength using an isokinetic dynamometer
Leg power
Time frame: Change from baseline strength at 11 weeks
Dynamic leg power assessed through jump height on force platform
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 27 Mar 2018.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil in people with Exercise-induced Inflammation, run by Loughborough University at 1 site in United Kingdom.
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 2 inclusion and 10 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 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Strength (time frame: Change from baseline strength at 11 weeks). The study lists 2 primary outcomes in all. 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 27 Mar 2018.