NCT05604586已完成不适用
Assessment of the Impact of N-acetylcysteine Supplementation on Physical Performance Depending on the Polymorphism of Genes Related to Glutathione Metabolism
Poznan University of Life Sciences2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Assesment of change in results of time trial test
研究概览
简要总结
Study aims to verify the hypothesis:
- N-acetylcysteine (NAC) supplementation improves exercise capacity in people training endurance sports and the effectiveness of this supplementation depends on the polymorphism of genes related to folate and glutathione metabolism.
- NAC supplementation affects the parameters of oxidative stress among women and men training endurance disciplines
详细描述
- Glutathione depletion caused by a combination of intense physical exertion associated with the generation of significant amounts of reactive oxygen species (ROS), and possibly with having an unfavorable variant of the methylenetetrahydrofolate reductase (MTHFR), glutamate-cysteine ligase catalytic subunit (GCLC); glutamate-cysteine ligase modifier subunit (GCLM); glutathione S-transferase Pi 1 (GSTP1); glutathione synthetase (GSS) or cystathionine-β-synthase (CBS) genes may contribute to lower adaptation to exercise, but also to deterioration of health of people training endurance sports.
- The main objective of the study is to verify the hypothesis that NAC supplementation has a beneficial effect on regeneration between intense exercise tests simulating a race characteristic for a given discipline. In addition, this study is aimed at checking whether genotype may modify the effectiveness of the supplementation measured as exercise and biochemical parameters . A double-blind study involving 100 women and men supplementing 1200 mg of N-acetylcysteine daily or 1200 mg of rice flour in three equal doses. Supplementation will last for 7 days. Blood sampling and body composition testing will be performed in the morning of the exercise test day. Discipline-specific exercise testing will be performed before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant/investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent to participate in the study and acceptance of the established scheme for conducting the intervention
- •age range between 18 and 45 years old
- •regular training with a frequency of at least 3 times a week during the last year,
排除标准
- •no consent to participate in the study and no acceptance of the established scheme of the conducted intervention
- •existing diseases of the blood system and neoplastic diseases
- •respiratory system diseases
- •any medical contraindications to exercise
- •Results obtained from exercise tests that do not meet the inclusion criteria
- •use of NAC during the last month
- •allergy to NAC
- •pregnancy and lactation
研究组 & 干预措施
Placebo
Placebo Comparator
Supplement: Placebo Participants will undergo two exercise tests and daily supplementation with placebo orally in three doses a day for seven consecutive days.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Assesment of change in results of time trial test
时间窗: Baseline,1 week
(min/test) change within groups and between groups
次要结局
- Oxidized glutathione (GSSG)(Baseline,1 week)
- Homocysteine (Hcy)(Baseline,1 week)
- Blood HDL-cholesterol (HDL-C)(Baseline,1 week)
- Blood triacylglycerol (TAG)(Baseline,1 week)
- Dietary intake(Baseline,1 week)
- Carbon dioxide volume (VCO2)(Baseline,1 week)
- Cortisol (C)(Baseline,1 week)
- Fat Free Mass (FFM)(Baseline, 1 week)
- aspartate aminotransferase (ASPAT)(1 week)
- Alanine transaminase (ALAT)(Baseline,1 week)
- Reduced glutathione (GSH)(Baseline,1 week)
- Total cholesterol (TChol)(Baseline,1 week)
- Testosterone (T)(Baseline,1 week)
- Body mass(BM)(Baseline, 1 week)
- Blood LDL-cholesterol (LDL-C)(1 week)
- Oxygen volume (VO2)(Baseline,1 week)
- Fat Mass% (FM%)(Baseline, 1 week)
- Thiobarbituric Acid Reactive Species (TBARS)(1 week)
研究者
研究点 (2)
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