NCT05520437

Brief Summary

The purpose of the current study is to explore the effect of omega-3 fatty acids supplementation on stress-induced changes to kynurenine metabolism and mood. The objectives of this research project are as follows:

  1. 1.To compare biochemical parameters (KYN and KYNA, markers of oxidative stress, and markers of inflammation) between physically active and inactive males
  2. 2.To determine the impact of a 3-month supplementation with omega-3 fatty acids on mood, inflammation markers and oxidative stress, and changes in KYN and KYNA
  3. 3.To determine the impact of the stress manipulation test (TSST) on mood and changes in KYN and KYNA before and after the omega-3 fatty acids supplementation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 20, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

July 14, 2021

Last Update Submit

August 28, 2022

Conditions

Keywords

Omega-3Kynurenine pathway

Outcome Measures

Primary Outcomes (1)

  • Kynurenine pathway and its metabolites

    Before the intervention and 12 weeks after the start of the intervention blood samples will be collected from the participants to determine kynurenine pathway and its metabolites, namely Xanthurenic acid \[ng/mL\], Kynurenic acid \[ng/mL\], Kynurenine \[ng/mL\] and 3-Hydroxykynurenine \[ng/mL\]. This will be followed by inducing a stress response with the Trier Social Stress Test (TSST) in both groups of participants. Straight after TSST and one hour after the stress manipulation test Xanthurenic acid \[ng/mL\], Kynurenic acid \[ng/mL\], Kynurenine \[ng/mL\] and 3-Hydroxykynurenine \[ng/mL\] will be reassessed.

    3 months

Secondary Outcomes (5)

  • Mood

    3 months

  • Mood

    3 months

  • Omega-3 fatty acids

    3 months

  • Inflammation markers

    3 months

  • Oxidative stress

    3 months

Study Arms (2)

Physically active males

EXPERIMENTAL

Half of the study population will consist of long-distance runners with 2-5 years of experience in running and similar times in covering the half-marathon distance.

Dietary Supplement: Omega-3 fatty acidsDietary Supplement: Placebo

Physically inactive males

EXPERIMENTAL

The other half of the study population will consist of age-matched individuals involved in no regular physical activity.

Dietary Supplement: Omega-3 fatty acidsDietary Supplement: Placebo

Interventions

Omega-3 fatty acidsDIETARY_SUPPLEMENT

Participants received Omega-3 supplements (NAMEDSPORT) in the form of softgels over a period of 12 weeks. The supplement is certified by the International Fish Oil Standards™ (IFOS™) Program. Daily dose contained a total of 3276 mg of Omega 3 (4000 mg of fish oil of which: EPA 2234mg; DHA 916mg).

Physically active malesPhysically inactive males
PlaceboDIETARY_SUPPLEMENT

Participants will receive a placebo in the form of MCT oil capsules with no effect on the hypothesized outcome.

Physically active malesPhysically inactive males

Eligibility Criteria

Age28 Years - 48 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • long-distance runners with 2-5 years of experience in running and similar times in covering the half-marathon distance
  • age-matched individuals involved in no regular physical activity
  • must provide a signed informed consent form

You may not qualify if:

  • DSM-5 psychiatric diagnoses other than depression and anxiety disorders (American Psychiatric Association, 2013)
  • neurological disorders any other serious medical problems
  • taking dietary supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Gdańsk

Gdansk, 80-210, Poland

Location

Related Publications (2)

  • Bidzan-Wiacek M, Tomczyk M, Blazek M, Mika A, Antosiewicz J. No Effects of Omega-3 Supplementation on Kynurenine Pathway, Inflammation, Depressive Symptoms, and Stress Response in Males: A Placebo-Controlled Trial. Nutrients. 2024 Oct 31;16(21):3744. doi: 10.3390/nu16213744.

  • Tomczyk M, Bidzan-Wiacek M, Kortas JA, Kochanowicz M, Jost Z, Fisk HL, Calder PC, Antosiewicz J. Omega-3 fatty acid supplementation affects tryptophan metabolism during a 12-week endurance training in amateur runners: a randomized controlled trial. Sci Rep. 2024 Feb 19;14(1):4102. doi: 10.1038/s41598-024-54112-x.

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2021

First Posted

August 30, 2022

Study Start

November 20, 2020

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

August 30, 2022

Record last verified: 2022-08

Locations