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临床试验/NCT02937363
NCT02937363已完成不适用

Effects of Alpha Lipoic Acid Supplementation in G6PD Deficient Individuals After Acute Exercise

University of Thessaly2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Change in redox status after exercise

研究概览

简要总结

The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation on redox status, physiological and biochemical parameters in G6PD deficient individuals after acute exercise.

详细描述

In a randomized double-blind, crossover design, 12 adult volunteers with G6PD deficiency of both sexes will be supplemented with either 600 mg of alpha-lipoic acid (experimental condition - EC) or placebo (control condition - CC) every day for 4 weeks. Before intervention, all participants will be informed about the study protocol, fill a medical history questionnaire and sign an informed consent form. Moreover, measurements of anthropometric characteristics and physiological parameters, as well as a VO2max test will be performed.

Participants will perform 4 trials of exercise (70% VO2max for 45min and 90% till exhaustion) before and after each condition. Blood samples will be collected before, immediately after and 1 hour after exercise. Moreover, measurements of anthropometric characteristics and physiological parameters will be performed before and after each condition. There will be a washout period of at 4 weeks between conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • G6PD deficiency

排除标准

  • Any uncontrolled health condition for which exercise is contraindicated
  • Current use of dietary supplements or drugs
  • Pregnant, pregnancy intention or breast feeding

研究组 & 干预措施

Alpha-lipoic acid

Experimental

Alpha-lipoic acid supplementation (600 mg/day) for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.

干预措施: Alpha-lipoic acid (Dietary Supplement)

Placebo

Placebo Comparator

Placebo administration for 4 weeks in a counterbalanced manner to 12 G6PD deficient individuals.

干预措施: Placebo (Other)

结局指标

主要结局

Change in redox status after exercise

时间窗: Before, immediately after and 1 hour after each trial of exercise

Indices of blood redox status

次要结局

  • Body composition(Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo)
  • Blood pressure(Before and after 4 weeks of alpha-lipoic acid supplementation, before and after 4 weeks of placebo)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Athanasios Z. Jamurtas

Professor

University of Thessaly

研究点 (2)

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