Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue FunctionsPhase 3NCT04780451
Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners.
A Phase 3 study testing Omega-3 supplementation in recreational runners in people with Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
Recreational male runners participated in 12 weeks training and omega-3 supplementation programme. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed. Read more about this study
- Who is it for?
- Ages 29 to 42 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions
- What is being tested?
- Omega-3 supplementation in recreational runners
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 16 Sep 2020to 2 Mar 2021
- Phase
- Phase 3
- 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 29 to 42 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non smoking
- no chronic diseases
- no supplements and medicines
- personal best in 10km run between 35 and 59 min at the turn of 2016 and 2020 y
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 12 Weeks of Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners. The Potential Role of the Myokines-NO Pathway.
Recreational male runners participated in 12 weeks training and omega-3 supplementation programme. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
Read the detailed description
40 healthy, recreational male runners participated in 12 weeks training and supplementation programme. The training protocol was built based on undulatory load manipulation 3:1, which was suggested to be effective to prevent overtraining and stress due to oscillations between volume/intensity. Throughout the study all participants took 4 identical-looking capsules per day (2 in the morning and 2 in the evening) containing either omega-3 fatty acids or medium chain triglycerides as placebo in total amount of 4g of fat per day. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed. Additionally, blood was collected to determine the concentrations of selected proteins (including eNOS, irisin, adiponectin) that may be associated with potential changes in participants' oxygen uptake during the treadmill test.
- Being tested
- Omega-3 supplementation in recreational runners
- Keywords
- omega-3, supplementation, endurance training, running
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 supplementation in recreational runnersDietary supplement
Male recreational runners participated in 12 weeks of endurance training combined with omega-3 fatty acids supplementation. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
| Study group | Role | What they receive |
|---|---|---|
| Omega | Experimental | Not described Receives: Dietary Supplement: Omega-3 supplementation in recreational runners |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Omega-3 supplementation in recreational runners |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in oxygen consumption during running test
Measured: between 10 and 25 minutes of the running test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start16 Sep 2020
- Primary completion20 Dec 2020
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue FunctionsStudies 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk, University of Southampton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780451
- Sponsor's protocol ID
- 2018/31/N/NZ7/02962
- Status last verified
- Feb 2021
- First submitted
- 2 Mar 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Weeks of Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners. The Potential Role of the Myokines-NO Pathway.
- ClinicalTrials.gov ID
- NCT04780451
- Acronym / sponsor ID
- 2018/31/N/NZ7/02962
- Keywords
- omega-3, supplementation, endurance training, running
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Collaborators
- Medical University of Gdansk, University of Southampton
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 3 Mar 2021 (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.
Recreational male runners participated in 12 weeks training and omega-3 supplementation programme. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
Detailed description
40 healthy, recreational male runners participated in 12 weeks training and supplementation programme. The training protocol was built based on undulatory load manipulation 3:1, which was suggested to be effective to prevent overtraining and stress due to oscillations between volume/intensity. Throughout the study all participants took 4 identical-looking capsules per day (2 in the morning and 2 in the evening) containing either omega-3 fatty acids or medium chain triglycerides as placebo in total amount of 4g of fat per day. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed. Additionally, blood was collected to determine the concentrations of selected proteins (including eNOS, irisin, adiponectin) that may be associated with potential changes in participants' oxygen uptake during the treadmill test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega | Experimental | Dietary Supplement: Omega-3 supplementation in recreational runners |
| Placebo | Placebo comparator | Dietary Supplement: Omega-3 supplementation in recreational runners |
Who may qualify
- Ages
- 29 to 42 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non smoking
- no chronic diseases
- no supplements and medicines
- personal best in 10km run between 35 and 59 min at the turn of 2016 and 2020 y
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Omega-3 supplementation in recreational runnersMale recreational runners participated in 12 weeks of endurance training combined with omega-3 fatty acids supplementation. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed. | Dietary supplement | Omega, Placebo |
Primary outcome
changes in oxygen consumption during running test
Time frame: between 10 and 25 minutes of the running test
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 3 Mar 2021.
Related trials for Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 supplementation in recreational runners in people with Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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 4 inclusion and 1 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 3 Mar 2021. 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 Poland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in oxygen consumption during running test (time frame: between 10 and 25 minutes of the running test). 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 3 Mar 2021.