NCT07237113

Brief Summary

In recent decades, omega-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been proposed as potential therapeutic agents for minimizing muscle damage induced by eccentric exercise, especially when supplementation is long-term (\> 6 weeks) and at high doses (\> 1 g/d). However, no study has analyzed whether these effects are mediated by an increase in oxylipins (metabolites derived from EPA and DHA), which play an essential role in the muscle regeneration process. The objective of the present study is to determine the effect of eight weeks of high-dose omega-3 fatty acid supplementation on blood oxylipin levels and their association with muscle function and markers of muscle damage after high-intensity eccentric exercise in young men.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
Last Updated

November 19, 2025

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

omega-3oxylipinsexercise-induced muscle damagespecialized pro-resolving mediators

Outcome Measures

Primary Outcomes (2)

  • Maximum isometric voluntary contraction strength loss

    Change in MVC strength loss 0, 2, 24, 48, and 72 hours after.

    Pre and post intervention (8 weeks)

  • Plasma oxylipins

    Levels of plasma oxylipins

    Pre and post intervention (8 weeks)

Secondary Outcomes (8)

  • Peak aerobic capacity

    Pre and post intervention (8 weeks)

  • Dietary assessment

    Pre and post intervention (8 weeks)

  • Fatty acid composition

    Pre and post intervention (8 weeks)

  • Thigh circumference

    Pre and post intervention (8 weeks)

  • Creatine kinase

    Pre and post intervention (8 weeks)

  • +3 more secondary outcomes

Study Arms (2)

Placebo control

PLACEBO COMPARATOR

The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule.

Dietary Supplement: Placebo

Omega-3

EXPERIMENTAL

The participants will be supplemented with 5 capsules per day of Omega UP (Newscience, Chile) equivalent to 2.5 g/d of DHA and 0.5 g/d of EPA.

Dietary Supplement: Omega

Interventions

PlaceboDIETARY_SUPPLEMENT

The participants will be supplemented with 5 capsules per day of a placebo-filled gelatin capsule for 8 weeks.

Placebo control
OmegaDIETARY_SUPPLEMENT

The participants will be supplemented with 5 capsules per day of Omega UP (Newscience, Chile), equivalent to 2.5 g/d of DHA and 0.5 g/d of EPA for 8 weeks

Omega-3

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male participants between 18 and 40 years

You may not qualify if:

  • Participants must not have performed regular strength training during the 6 months prior to the start of the study.
  • Participants must also not be taking medications that affect inflammation or cardiovascular responses to exercise and must have a BMI of less than 30 kg/m2.
  • Participants must not consume fish more than twice a week and must not have taken any omega-3 supplements for three months prior to the study or be allergic to fish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de O'Higgins

Rancagua, Libertador Bernardo O'Higgins, 2820000, Chile

Location

Related Publications (11)

  • Penailillo L, Blazevich A, Numazawa H, Nosaka K. Metabolic and muscle damage profiles of concentric versus repeated eccentric cycling. Med Sci Sports Exerc. 2013 Sep;45(9):1773-81. doi: 10.1249/MSS.0b013e31828f8a73.

  • Lv ZT, Zhang JM, Zhu WT. Omega-3 Polyunsaturated Fatty Acid Supplementation for Reducing Muscle Soreness after Eccentric Exercise: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Biomed Res Int. 2020 Apr 20;2020:8062017. doi: 10.1155/2020/8062017. eCollection 2020.

  • Levy BD, Clish CB, Schmidt B, Gronert K, Serhan CN. Lipid mediator class switching during acute inflammation: signals in resolution. Nat Immunol. 2001 Jul;2(7):612-9. doi: 10.1038/89759.

  • Gabbs M, Leng S, Devassy JG, Monirujjaman M, Aukema HM. Advances in Our Understanding of Oxylipins Derived from Dietary PUFAs. Adv Nutr. 2015 Sep 15;6(5):513-40. doi: 10.3945/an.114.007732. Print 2015 Sep.

  • Markworth JF, Maddipati KR, Cameron-Smith D. Emerging roles of pro-resolving lipid mediators in immunological and adaptive responses to exercise-induced muscle injury. Exerc Immunol Rev. 2016;22:110-34.

  • Tsuchiya Y, Yanagimoto K, Nakazato K, Hayamizu K, Ochi E. Eicosapentaenoic and docosahexaenoic acids-rich fish oil supplementation attenuates strength loss and limited joint range of motion after eccentric contractions: a randomized, double-blind, placebo-controlled, parallel-group trial. Eur J Appl Physiol. 2016 Jun;116(6):1179-88. doi: 10.1007/s00421-016-3373-3. Epub 2016 Apr 16.

  • Ramos-Campo DJ, Avila-Gandia V, Lopez-Roman FJ, Minarro J, Contreras C, Soto-Mendez F, Domingo Pedrol JC, Luque-Rubia AJ. Supplementation of Re-Esteri fi ed Docosahexaenoic and Eicosapentaenoic Acids Reduce Inflammatory and Muscle Damage Markers after Exercise in Endurance Athletes: A Randomized, Controlled Crossover Trial. Nutrients. 2020 Mar 9;12(3):719. doi: 10.3390/nu12030719.

  • Gerling CJ, Mukai K, Chabowski A, Heigenhauser GJF, Holloway GP, Spriet LL, Jannas-Vela S. Incorporation of Omega-3 Fatty Acids Into Human Skeletal Muscle Sarcolemmal and Mitochondrial Membranes Following 12 Weeks of Fish Oil Supplementation. Front Physiol. 2019 Mar 29;10:348. doi: 10.3389/fphys.2019.00348. eCollection 2019.

  • BLIGH EG, DYER WJ. A rapid method of total lipid extraction and purification. Can J Biochem Physiol. 1959 Aug;37(8):911-7. doi: 10.1139/o59-099. No abstract available.

  • MORRISON WR, SMITH LM. PREPARATION OF FATTY ACID METHYL ESTERS AND DIMETHYLACETALS FROM LIPIDS WITH BORON FLUORIDE--METHANOL. J Lipid Res. 1964 Oct;5:600-8. No abstract available.

  • Gabbs M, Zahradka P, Taylor CG, Aukema HM. Time Course and Sex Effects of alpha-Linolenic Acid-Rich and DHA-Rich Supplements on Human Plasma Oxylipins: A Randomized Double-Blind Crossover Trial. J Nutr. 2021 Mar 11;151(3):513-522. doi: 10.1093/jn/nxaa294.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The masking process will ensure that both the participants and the investigators involved in the study remain unaware of the treatment assignments throughout the entire duration of the study. A unique identification code will be assigned to each participant upon enrollment, which conceals their treatment allocation. The allocation sequence will be generated by a person not directly involved in the study. The capsules in the experimental intervention and the control treatment, will be packaged identically to maintain visual similarity. The packaging materials and labeling will be designed to be indistinguishable between the two groups. In addition, all outcome assessments and data collection procedures will be performed by personnel who are blinded to the treatments
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a double-blind manner to two supplementation groups: (a) placebo (yellow maltodextrin) or (b) omega-3 (EPA and DHA). Prior to the start of the supplementation period, participants will undergo venous blood sampling, indirect markers of muscle damage testing, oxygen consumption testing, and the eccentric exercise protocol on one leg (6 sets of 10 repetitions at 80% of 1 repetition maximum). Immediately after, 1, 2, 24, 48, 72, and 96 hours after the eccentric exercise session, muscle damage will be assessed, and venous blood samples will be obtained. The following day, participants will begin their 8-week supplementation protocol with omega-3 or a placebo. After the supplementation period, participants will perform the same tests as at the beginning and will perform the eccentric exercise session on the opposite leg.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

September 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

November 19, 2025

Record last verified: 2021-08

Locations