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临床试验/NCT05520437
NCT05520437Unknown不适用

Omega-3 Fatty Acids Supplementation on Stress-induced Changes to Kynurenine Metabolism and Mood in Physically Active and Inactive Males

Medical University of Gdansk2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Kynurenine pathway and its metabolites

研究概览

简要总结

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. To compare biochemical parameters (KYN and KYNA, markers of oxidative stress, and markers of inflammation) between physically active and inactive males
  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. 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

详细描述

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:

  1. To compare biochemical parameters (KYN, KYNA, markers of oxidative stress, and inflammation) between physically active and inactive males
  2. To determine the impact of a 3-month supplementation with omega-3 fatty acids on changes in the kynurenine and kynurenic acid
  3. To determine the impact of a 3-month supplementation with omega-3 fatty acids on inflammation markers and oxidative stress
  4. To determine the impact of a 3-month supplementation with omega-3 fatty acids on mood
  5. 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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
28 Years 至 48 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Kynurenine pathway and its metabolites

时间窗: 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.

次要结局

  • Omega-3 fatty acids(3 months)
  • Oxidative stress(3 months)
  • Mood(3 months)
  • Inflammation markers(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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