- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780451
Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners.
March 2, 2021 updated by: Gdansk University of Physical Education and Sport
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gdańsk, Poland, 80-336
- Gdansk University of Physical Education and Sport
-
-
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
29 years to 42 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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.
|
Experimental: Omega
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in oxygen consumption during running test
Time Frame: between 10 and 25 minutes of the running test
|
between 10 and 25 minutes of the running test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 16, 2020
Primary Completion (Actual)
December 20, 2020
Study Completion (Actual)
March 2, 2021
Study Registration Dates
First Submitted
March 2, 2021
First Submitted That Met QC Criteria
March 2, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018/31/N/NZ7/02962
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.
Clinical Trials on Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions
-
Mark GlaisterNot yet recruitingThe Focus of the Study is to Investigate the Effects of Phosphatidylserine Supplementation on Exercise Physiology and Cycling Time-trial Performance
-
University of Sao PauloSuspendedEffect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and StrenghtBrazil
-
University of CopenhagenRigshospitalet, DenmarkRecruitingNeoplasms | Quality of Life | Insulin Resistance | Exercise | Body Composition | Sarcopenia | Cachexia | Physical Functional Performance | Muscle, Skeletal | Patient Reported Outcome Measures | Gastrointestinal Microbiome | Metabolism | Caregivers | Adipose Tissue | Proteomics | Mitochondria | Lipidomics | EpigenomicsDenmark
Clinical Trials on Omega-3 supplementation in recreational runners
-
Eduardo NgCanadian Diabetes AssociationCompletedType 1 DiabetesCanada
-
The Hospital for Sick ChildrenCanadian Foundation for AIDS Research (CANFAR); The Physicians' Services Incorporated... and other collaboratorsTerminatedHypertriglyceridemiaCanada
-
National Center for Complementary and Integrative...Office of Dietary Supplements (ODS)CompletedStress-related Changes in InflammationUnited States
-
Lauren NyeUniversity of Kansas Medical Center; American Cancer Society, Inc.Active, not recruitingBreast CancerUnited States
-
Bethan HusseyUnknown
-
University Hospital, Basel, SwitzerlandUniversitäre Psychiatrische Kliniken (UPK) BaselTerminated
-
Zhejiang UniversityUnknownHyperlipidemias | Hyperglycaemia (Diabetic)China
-
Ohio State UniversityNational Institute on Aging (NIA)Completed
-
L. Eugene ArnoldNational Institute of Mental Health (NIMH)CompletedBipolar DisorderUnited States
-
Amasya UniversityGazi UniversityCompleted