AzTrials
AzTrials

HealthyNCT07134140

Omega-3 Fatty Acids in Muscle Function and Health

A study testing Omega-3 in people with Healthy, run by European University Cyprus at 1 site in Cyprus.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to investigate the effects of omega-3 fatty acid supplementation on muscle performance, neuromuscular function, inflammation, and oxidative stress at rest and after eccentric exercise. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Omega-3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteCyprus
Study dates
Sep 2025to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body Mass Index (BMI) within the normal range (18.5-25 kg/m²).
  • Healthy individuals without severe medical conditions (e.g., diabetes, coronary artery disease, hypertension, neuromuscular disorders).
  • No musculoskeletal injury in the lower limbs (e.g., bone fracture, tendon rupture, grade III muscle strain) within the last 6 months before enrollment.
  • Negative responses to all questions on the PAR-Q questionnaire indicating no contraindications to participating in exercise testing.
  • Mentally capable of providing informed consent.

Who cannot join

  • Use of any pharmaceutical medications (e.g., statins, aspirin, ibuprofen).
  • Use of dietary supplements (e.g., protein, vitamins) within the last 3 months before enrollment.
  • Participation in a structured training program involving more than three training sessions per week during the study period.
  • Following a special diet (e.g., intermittent fasting, ketogenic diet, vegetarian diet).
  • Allergy or intolerance to fish oil or olive oil.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anastasios A Theodorou, Dr contact

22713110

A.Theodorou@euc.ac.cy

Cyprus1 site
  • European University Cyprus

    Nicosia, Engomi, 1516

    Anastasios Theodorou, Dr., 22713110, A.Theodorou@euc.ac.cy

Other trials in Cyprus

About this study

Official title: Effects of Omega-3 Fatty Acid Supplementation on Muscle Performance, Neuromuscular Function, and Inflammation at Rest and Following Eccentric Exercise.

This study aims to investigate the effects of omega-3 fatty acid supplementation on muscle performance, neuromuscular function, inflammation, and oxidative stress at rest and after eccentric exercise. The findings may provide insights into the role of omega-3 fatty acids in muscle function, physiology, and metabolism following muscle-damaging exercise. Additionally, the effects of omega-3 fatty acids on cardiovascular health will be investigated.

Read the detailed description

The study is a double-blind, randomized controlled trial. Two parallel groups of 16 healthy males and females each (sex counterbalanced, 20-45 years) will randomly take 3 g of fish oil [1500 mg EPA (eicosapentaenoic acid) + 750 mg DHA (docosahexaenoic acid), Now Foods, USA] or a placebo (3 g of olive oil) for 12 weeks. Before taking the supplement, participants will perform a unilateral isokinetic eccentric exercise session of maximal voluntary intensity (10 repetitions x 10 sets of knee extensions at a speed of 60 degrees per second). Dominant and non-dominant legs will be allocated equally and randomly across participants. Physiological assessments and blood samples will be collected immediately before exercise and 2 and 4 days after eccentric exercise (bout 1). Then, participants will start the supplementation for 12 weeks. At the end of the supplementation period, participants will perform the same eccentric exercise protocol (bout 2) with their opposite leg. The same assessments and blood sampling will be conducted at the same time points (i.e., immediately before and 2 and 4 days after eccentric exercise).

Conditions
Healthy
Being tested
Omega-3, Placebo comparator
Keywords
omega-3, eccentric exercise, muscle function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3Dietary supplement

    Participants will take three capsules per day (a total of 1,500 mg EPA and 750 mg DHA). They will take 1 g with each main meal (breakfast, lunch, and dinner).

  • Placebo comparatorDietary supplement

    Participants will take 3 g of olive oil. They will take 1 g with each main meal (breakfast, lunch, and dinner).

Study groups in NCT07134140
Study groupRoleWhat they receive
Omega-3ExperimentalParticipants in this group will take 3 g of fish oil [(NOW, Ultra Omega-3 Fish Oil, (NOW, Bloomingdale, IL, USA)] for 12 weeks.
Receives: Dietary Supplement: Omega-3
PlaceboPlacebo comparatorParticipants in this group will take 3 g of olive oil for 12 weeks.
Receives: Dietary Supplement: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle Strength

    Muscle strength of the knee extensors will be measured using an isokinetic dynamometer during maximal voluntary contractions. The unit of measure is Newton-meters (Nm).

    Measured: Changes in muscle strength after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  2. Maximal Oxygen Uptake (VO₂ max)

    VO₂ max will be assessed during a graded exercise test on a cycle ergometer. The measure unit is milliliters per kilogram of body mass per minute (ml/kg/min).

    Measured: Changes in VO₂ max after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  3. Muscle Fatigue Index (MFI)

    MFI will be calculated as the percentage decline (%) in peak torque across a series of repeated maximal contractions of the knee extensor muscles on an isokinetic dynamometer.

    Measured: Changes in MFI after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  4. Muscle Oxygenation

    Muscle oxygenation will be measured in the vastus lateralis using near-infrared spectroscopy (NIRS). Parameters include oxyhemoglobin (O₂Hb), deoxyhemoglobin (HHb), and total hemoglobin levels, which will be expressed in arbitrary units (AU).

    Measured: Changes in muscle oxygenation after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  5. Creatine Kinase

    Creatine kinase activity will be measured in International Units (IU) via the enzymatic colorimetric method in fasting plasma samples.

    Measured: Change in creatine kinase activity after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  6. Range of Motion (ROM)

    ROM of the knee joint will be measured in degrees (°) using an isokinetic dynamometer, with full extension defined as 0° and flexion recorded up to 120°.

    Measured: Change in ROM after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  7. Muscle Thickness

    Muscle thickness of the vastus lateralis will be measured using B-mode ultrasound with a linear probe, in millimeters (mm).

    Measured: Change in muscle thickness after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  8. Echo Intensity

    Echo intensity of the vastus lateralis will be assessed using B-mode ultrasound with a linear probe and quantified from grayscale image analysis, expressed in arbitrary units (0-255).

    Measured: Change in echo intensity after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  9. Blood Lipids Profile

    Fasting blood samples will be collected and analyzed to assess the participant's lipid profile, including: Total Cholesterol (TC). Expressed in mg/dL. Low-Density Lipoprotein Cholesterol (LDL-C). Expressed in mg/dL. High-Density Lipoprotein Cholesterol (HDL-C). Expressed in mg/dL. Triglycerides (TG). Expressed in mg/dL. Blood will be drawn after a minimum of 8-12 hours of fasting. Lipid concentrations will be determined using standard enzymatic colorimetric methods on an automated clinical chemistry analyzer.

    Measured: Change in blood lipids from baseline (immediately before supplementation) to 12 weeks after the supplementation period.

Secondary outcomes (21)
  1. Omega-3 Index

    The Omega-3 Index will be assessed as a biomarker of long-chain omega-3 fatty acid status. It is defined as the combined percentage (%) of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in red blood cell (RBC) membranes, expressed as a proportion of total identified fatty acids.

    Blood samples will be collected following an overnight fast, and red blood cells will be isolated for fatty acid analysis. EPA and DHA levels will be quantified via gas chromatography, and the Omega-3 Index will be reported as a percentage (%).

    Measured: Change in omega-3 index in red blood cells from baseline (immediately before supplementation) to 12 weeks after the supplementation period.

  2. Rate of Force Development (RFD).

    RFD will be calculated as the slope of the torque-time curve during the early phase of voluntary contraction. It will be measured in Newton-meters per second (Nm/s).

    Measured: Change in RFD after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  3. Electromechanical Delay (EMD)

    EMD will be defined as the time lag between the onset of electrical activity (via surface EMG) and the onset of force production, measured in milliseconds (ms).

    Measured: Change in EMD after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  4. Force Matching Error (FME)

    FME will be assessed during a submaximal isometric contraction using an isokinetic dynamometer and expressed as the percentage difference between the target and produced force (%).

    Measured: Change in FME after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  5. Joint Position Sense (JPS)

    JPS will be evaluated as the absolute angular difference between a target knee joint angle and the participant's reproduced angle, measured in degrees (°) using an isokinetic dynamometer.

    Measured: Change in JPS after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  6. Delayed Onset Muscle Soreness (DOMS).

    DOMS will be assessed using a 1-10 visual analog scale (VAS), where 1 indicates no pain and 10 indicates extreme pain.

    Measured: Change in DOMS after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  7. Countermovement Jump (CMJ)

    CMJ will be measured in centimeters (CM) using a force plate.

    Measured: Change in CMJ after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  8. Contact Time

    Duration of foot contact with the force plate during landing, expressed in milliseconds (ms).

    Measured: Change in contact time after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  9. Stability Index

    The stability index will be assessed from the center of pressure displacement using a force platform and expressed in millimeters (mm).

    Measured: Change in stability index after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  10. F2-Isoprostanes

    F2-Isoprostanes will be quantified as a marker of lipid peroxidation using ELISA and expressed in picograms per milliliter (pg/mL).

    Measured: Change in F2-Isoprostanes after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  11. Glutathione

    Glutathione will be measured as an indicator of endogenous antioxidant capacity using a colorimetric assay and expressed in micromoles per gram of hemoglobin (μmol/g Hb).

    Measured: Change in glutathione after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  12. Protein carbonyls

    Protein carbonyls will be measured as a marker of oxidative protein damage using a spectrophotometric assay and expressed in nanomoles per gram of hemoglobin (nmol/g Hb).

    Measured: Change in protein carbonyls after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  13. Interleukin-6 (IL-6)

    IL-6 will be measured as a marker of inflammation using ELISA and expressed in picograms per milliliter (pg/mL).

    Measured: Change in IL-6 after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  14. Tumor Necrosis Factor-alpha (TNF-α)

    TNF-α will be measured as a marker of inflammation using ELISA and expressed in picograms per milliliter (pg/mL).

    Measured: Change in TNF-α after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  15. Pennation Angle

    The pennation angle of the vastus lateralis will be measured under resting conditions using longitudinal B-mode ultrasound imaging and expressed in degrees (°).

    Measured: Change in pennation angle after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  16. Fascicle Length

    Fascicle length of the vastus lateralis will be determined under resting condition from B-mode ultrasound images, either measured directly from visible fascicles or estimated using trigonometric calculations, and expressed in millimeters

    Measured: Change in fascile length after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  17. Muscle Stiffness

    Muscle stiffness, reflecting the resistance of the muscle to an external force, will be measured and expressed in newtons per meter (N/m) using the Myoton Pro device.

    Measured: Change in muscle stifness after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  18. Muscle Tone

    Muscle tone will be assessed using the Myoton Pro device, representing the natural oscillation frequency of the muscle at rest, and expressed in hertz (Hz).

    Measured: Change in muscle tone after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  19. Mechanical Stress Relaxation Time

    Mechanical stress relaxation time will be assessed using the Myoton Pro device, representing the time required for the muscle to return to its original shape after a mechanical impulse, and expressed in milliseconds (ms).

    Measured: Change in mechanical stress relaxation time after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.

  20. Central and Peripheral Blood Pressure

    Central and peripheral systolic and diastolic blood pressure will be measured using the SphygmoCor system and expressed in millimeters of mercury (mmHg).

    Measured: Change in blood pressure from baseline (immediately before supplementation) to 12 weeks after the supplementation period.

  21. Arterial stiffness

    Arterial stiffness will be assessed using the SphygmoCor system by measuring carotid-femoral pulse wave velocity (PWV), expressed in meters per second (m/s).

    Measured: Change in arterial stiffness from baseline (immediately before supplementation) to 12 weeks after the supplementation period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134140
Sponsor's protocol ID
EUC omega-3
Status last verified
Aug 2025
First submitted
10 Aug 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the published results will be shared as supplementary files in accordance with the policies of each journal. Data sharing may vary across publications based on journal-specific requirements.

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 in people with Healthy, run by European University Cyprus at 1 site in Cyprus.

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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Aug 2025. 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 Cyprus. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anastasios A Theodorou, Dr (22713110, A.Theodorou@euc.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Strength (time frame: Changes in muscle strength after the first bout (week 0) and the second bout of exercise (week 12) from baseline (immediately before each bout) and at day 2 and day 4 after each exercise bout.). The study lists 9 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 21 Aug 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in