Omega-3 Fatty Acids in Muscle Function and Health

NCT07134140 | Not Yet Recruiting DMC

• 1 other identifier: EUC omega-3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy

Keywords

omega-3; eccentric exercise; muscle function

Outcome Measures

Primary Outcomes (9)

• 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).

  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.

• 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).

  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.

• 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.

  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.

• 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).

  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.

• Creatine Kinase

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

  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.

• 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°.

  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.

• Muscle Thickness

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

  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.

• 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).

  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.

• 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.

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

Secondary Outcomes (21)

• Omega-3 Index

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

• Rate of Force Development (RFD).

  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.

• Electromechanical Delay (EMD)

  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.

• Force Matching Error (FME)

  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.

• Joint Position Sense (JPS)

  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.

Study Arms (2)

Omega-3

EXPERIMENTAL

Participants in this group will take 3 g of fish oil \[(NOW, Ultra Omega-3 Fish Oil, (NOW, Bloomingdale, IL, USA)\] for 12 weeks.

Dietary Supplement: Omega-3

Placebo

PLACEBO COMPARATOR

Participants in this group will take 3 g of olive oil for 12 weeks.

Dietary Supplement: Placebo comparator

Interventions

Omega-3 DIETARY_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).

Omega-3

Placebo comparator DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University Cyprus: lead

Study Sites (1)

European University Cyprus

Nicosia, Engomi, 1516, Cyprus

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Anastasios A Theodorou, Dr.

  European University Cyprus

  STUDY CHAIR

Central Study Contacts

Anastasios A Theodorou, Dr

CONTACT

22713110; A.Theodorou@euc.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The de-identified dataset and supporting documentation will be made available beginning after the publication of the primary study results in a peer-reviewed journal, or within 24 months of final study completion (whichever occurs first). Data will remain accessible for 10 years thereafter.
• Access Criteria: De-identified individual participant data and supporting documentation (study protocol, statistical analysis plan, dataset) will be available to qualified researchers conducting methodologically sound proposals. Access will be granted after approval of a data access request and completion of a data use agreement. Data will be accessible through a secure institutional repository.

Locations

CY (1)