Omega-3 Fatty Acids in Muscle Function and Health

NCT ID: NCT07134140

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Omega-3

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

Group Type: EXPERIMENTAL

Omega-3

Intervention Type: 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).

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Omega-3

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo comparator

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European University Cyprus

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anastasios Theodorou

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasios A Theodorou, Dr.

Role: STUDY_CHAIR

European University Cyprus

Locations

European University Cyprus

Nicosia, Engomi, Cyprus

Countries

Cyprus

Central Contacts

Anastasios A Theodorou, Dr

Role: CONTACT

A.Theodorou@euc.ac.cy

22713110

Facility Contacts

Anastasios Theodorou, Dr.

Role: primary

A.Theodorou@euc.ac.cy

22713110

Other Identifiers

EUC omega-3

Identifier Type: -

Identifier Source: org_study_id