Stress-induced MoodNCT05520437
Effect of Omega-3 Fatty Acids on Kynurenine Metabolism and Mood
A study testing Omega-3 fatty acids in people with Stress-induced Mood and Kynurenine Pathway and Its Metabolites, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 48 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress-induced Mood, Kynurenine Pathway and Its Metabolites
- What is being tested?
- Omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 20 Nov 2020to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 48 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- DSM-5 psychiatric diagnoses other than depression and anxiety disorders (American Psychiatric Association, 2013)
- neurological disorders any other serious medical problems
- taking dietary supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omega-3 Fatty Acids Supplementation on Stress-induced Changes to Kynurenine Metabolism and Mood in Physically Active and Inactive Males
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:
- To compare biochemical parameters (KYN and KYNA, markers of oxidative stress, and markers of inflammation) between physically active and inactive males
- 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
- 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
Read the detailed description
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. While previous studies suggest that peripheral tryptophan conversion to KYN is activated by stress and inflammatory factors, the evidence is based on animal models only. Hence, this will be the first study to test this phenomenon on humans. Omega-3 fatty acids supplementation in this study aims to reduce the inflammatory factors. The stress response in participants will be experimentally controlled by conducting a stress manipulation task. Finally, based on the findings that exercise-induced PGC-1α expression in skeletal muscles might protect against stress-induced neurobiological mechanisms of depressed mood, the study will compare two groups of participants: passive individuals and physically active individuals who might have higher activity of KAT in skeletal muscles. This study design will allow to investigate the effect of long-term endurance training on L-kynurenine levels and mood. Considering a constant rise in the consumed ratio of omega-6/omega-3 as well as a more sedentary lifestyle and higher experienced stress in western countries, this study could have a great therapeutic potential and will expand our understanding of mechanisms of how diet and exercise can influence mood.
The objectives of this research project are as follows:
- To compare biochemical parameters (KYN, KYNA, markers of oxidative stress, and inflammation) between physically active and inactive males
- To determine the impact of a 3-month supplementation with omega-3 fatty acids on changes in the kynurenine and kynurenic acid
- To determine the impact of a 3-month supplementation with omega-3 fatty acids on inflammation markers and oxidative stress
- To determine the impact of a 3-month supplementation with omega-3 fatty acids on mood
- To determine the impact of the stress manipulation test (TSST) on kynurenine metabolism before and after the omega-3 fatty acids supplementation
Procedure
Prior to the study, participants will be outlined the study protocol and will be assured about the right to withdrawn at any time. Following this, a written informed consent will be obtained from all participants.
Before the start of the intervention blood samples will be collected from the participants to determine the percentage content of omega-3 fatty acids in the serum and red blood cell, KYN and KYNA, markers of oxidative stress (lipid peroxidation products, protein carbonyls), and inflammation markers (CRP, IL-10, TNF). Mood will be assessed using validated psychological measures: Mood Adjective Check List (UMACL) and the Depression, Anxiety and Stress Scale - 21 Items (DASS-21). This will be followed by inducing a stress response with a validated stress manipulation test, the Trier Social Stress Test (TSST) in both groups of participants. After the stress manipulation test, mood and biological parameters will be reassessed.
All participants will receive omega-3 supplementation for the period of 12 weeks.
12 weeks after the start of the intervention blood samples will be collected from the participants to determine the omega-3 fatty acid levels, KYN and KYNA, markers of oxidative stress (lipid peroxidation products, protein carbonyls), and inflammation markers (CRP, IL-10, TNF). Mood will be assessed using UMACL and DASS. This will be followed by inducing a stress response (TSST) in both groups of participants. Straight after the stress manipulation test, and 1 hour after the stress manipulation test, mood and biological parameters will be reassessed.
- Being tested
- Omega-3 fatty acids, Placebo
- Keywords
- Omega-3, Kynurenine pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
PlaceboDietary supplement
Participants will receive a placebo in the form of MCT oil capsules with no effect on the hypothesized outcome.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Omega-3 fatty acids; Dietary 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. Receives: Dietary Supplement: Omega-3 fatty acids; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Mood
Mood Adjective Check List (UMACL) will be used to assess mood (Mathews, Chamberlain \& Jones, 1990, adapted to Polish by Ewa Goryńska, 2005). UMACL measures mood in three dimensions of the core affect: Tense Arousal (minimum value: 9, maximum value: 36), Energetic Arousal (minimum value: 10, maximum value: 40), and Hedonic Tone (minimum value: 10, maximum value: 40), with higher scores representing higher levels of the mood dimensions.
Measured: 3 months
Mood
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) will be used to assess mood. DASS-21 measures the emotional states of depression, anxiety and stress (for each of the subscales the minimum value is 10 and the maximum value is 42, with higher scores representing higher levels of the emotional states).
Measured: 3 months
Omega-3 fatty acids
The percentage content of omega-3 fatty acids in the blood will be assessed (1) before the intervention (2) 12 weeks after the start of the intervention, (3) following the stress manipulation test (Trier Social Stress Test (TSST)), (4) and one hour after TSST.
Measured: 3 months
Inflammation markers
C-reactive protein (CRP) [mg/l] levels will be assessed (1) before the intervention (2) 12 weeks after the start of the intervention, (3) following the stress manipulation test (Trier Social Stress Test (TSST)), (4) and one hour after TSST.
Measured: 3 months
Oxidative stress
Lipid peroxidation products levels will be assessed (1) before the intervention (2) 12 weeks after the start of the intervention, (3) following the stress manipulation test (Trier Social Stress Test (TSST)), (4) and one hour after TSST.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start20 Nov 2020
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress-induced MoodStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- National Science Centre, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520437
- Sponsor's protocol ID
- 2019/35/N/NZ7/03757
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39519577Tomczyk 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.
PubMed 38374149
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids Supplementation on Stress-induced Changes to Kynurenine Metabolism and Mood in Physically Active and Inactive Males
- ClinicalTrials.gov ID
- NCT05520437
- Acronym / sponsor ID
- 2019/35/N/NZ7/03757
- Keywords
- Omega-3, Kynurenine pathway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- National Science Centre, Poland
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare biochemical parameters (KYN and KYNA, markers of oxidative stress, and markers of inflammation) between physically active and inactive males
- 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
- 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
Detailed description
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. While previous studies suggest that peripheral tryptophan conversion to KYN is activated by stress and inflammatory factors, the evidence is based on animal models only. Hence, this will be the first study to test this phenomenon on humans. Omega-3 fatty acids supplementation in this study aims to reduce the inflammatory factors. The stress response in participants will be experimentally controlled by conducting a stress manipulation task. Finally, based on the findings that exercise-induced PGC-1α expression in skeletal muscles might protect against stress-induced neurobiological mechanisms of depressed mood, the study will compare two groups of participants: passive individuals and physically active individuals who might have higher activity of KAT in skeletal muscles. This study design will allow to investigate the effect of long-term endurance training on L-kynurenine levels and mood. Considering a constant rise in the consumed ratio of omega-6/omega-3 as well as a more sedentary lifestyle and higher experienced stress in western countries, this study could have a great therapeutic potential and will expand our understanding of mechanisms of how diet and exercise can influence mood.
The objectives of this research project are as follows:
- To compare biochemical parameters (KYN, KYNA, markers of oxidative stress, and inflammation) between physically active and inactive males
- To determine the impact of a 3-month supplementation with omega-3 fatty acids on changes in the kynurenine and kynurenic acid
- To determine the impact of a 3-month supplementation with omega-3 fatty acids on inflammation markers and oxidative stress
- To determine the impact of a 3-month supplementation with omega-3 fatty acids on mood
- To determine the impact of the stress manipulation test (TSST) on kynurenine metabolism before and after the omega-3 fatty acids supplementation
Procedure
Prior to the study, participants will be outlined the study protocol and will be assured about the right to withdrawn at any time. Following this, a written informed consent will be obtained from all participants.
Before the start of the intervention blood samples will be collected from the participants to determine the percentage content of omega-3 fatty acids in the serum and red blood cell, KYN and KYNA, markers of oxidative stress (lipid peroxidation products, protein carbonyls), and inflammation markers (CRP, IL-10, TNF). Mood will be assessed using validated psychological measures: Mood Adjective Check List (UMACL) and the Depression, Anxiety and Stress Scale - 21 Items (DASS-21). This will be followed by inducing a stress response with a validated stress manipulation test, the Trier Social Stress Test (TSST) in both groups of participants. After the stress manipulation test, mood and biological parameters will be reassessed.
All participants will receive omega-3 supplementation for the period of 12 weeks.
12 weeks after the start of the intervention blood samples will be collected from the participants to determine the omega-3 fatty acid levels, KYN and KYNA, markers of oxidative stress (lipid peroxidation products, protein carbonyls), and inflammation markers (CRP, IL-10, TNF). Mood will be assessed using UMACL and DASS. This will be followed by inducing a stress response (TSST) in both groups of participants. Straight after the stress manipulation test, and 1 hour after the stress manipulation test, mood and biological parameters will be reassessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physically active males | Experimental | Dietary Supplement: Omega-3 fatty acids, Dietary Supplement: PlaceboHalf 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. |
| Physically inactive males | Experimental | Dietary Supplement: Omega-3 fatty acids, Dietary Supplement: PlaceboThe other half of the study population will consist of age-matched individuals involved in no regular physical activity. |
Who may qualify
- Ages
- 28 to 48 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- DSM-5 psychiatric diagnoses other than depression and anxiety disorders (American Psychiatric Association, 2013)
- neurological disorders any other serious medical problems
- taking dietary supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acidsParticipants 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). | Dietary supplement | Physically active males, Physically inactive males |
| PlaceboParticipants will receive a placebo in the form of MCT oil capsules with no effect on the hypothesized outcome. | Dietary supplement | Physically active males, Physically inactive males |
Primary outcome
Kynurenine pathway and its metabolites
Time frame: 3 months
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.
5 secondary outcomes
Mood
Time frame: 3 months
Mood
Time frame: 3 months
Omega-3 fatty acids
Time frame: 3 months
Inflammation markers
Time frame: 3 months
Oxidative stress
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Derived from this study: PubMed 39519577Bidzan-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.
- Derived from this study: PubMed 38374149Tomczyk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acids in people with Stress-induced Mood and Kynurenine Pathway and Its Metabolites, run by Medical University of Gdansk at 1 site in Poland.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2022. 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 Poland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kynurenine pathway and its metabolites (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05520437, which also lists 2 linked publications.
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 30 Aug 2022.