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临床试验/NCT03672786
NCT03672786已完成不适用

Gene Expression in Nutritional Intervened Athletes

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年8月15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
入组人数
26
试验地点
2
主要终点
Gene expression analysis

研究概览

简要总结

Background: Exercise represents an important challenge for the homeostasis of the entire body that occurs on a cellular and systemic level in which micronutrients play an important role in regulating the processes that sustain athletic performance. Objective: The investigators measured changes in gene expression of whole blood in a group of athletes and sedentary participants and compared gene modulation before and after nutritional intervention with micronutrients. Methods: Blood samples were taken from thirteen athletes and thirteen sedentary age- and gender-matched participants. The study design was carried out over a period of 4 months where three time points were established: (T0) baseline conditions in the sedentary and athlete groups; (T2) after two months of supplementation; (T4) after two months in the absence of nutritional supplementation. Differential gene expression was evaluated in 112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System.

详细描述

Background: Exercise represents an important challenge for the homeostasis of the entire body that occurs on a cellular and systemic level in which micronutrients play an important role in regulating the processes that sustain athletic performance. Objective: The investigators measured changes in gene expression of whole blood in elite athletes and sedentary subjects and compared gene modulation before and after nutritional intervention with micronutrients. Methods: Thirteen elite athletes and thirteen sedentary controls were enrolled in the present study. Blood samples were taken from athletes and sedentary age- and gender-matched subjects. The study design was carried out over a period of 4 months where three time points were established: (T0) baseline conditions in the sedentary and handball groups; (T2) after two months of supplementation; (T4) after two months in the absence of nutritional supplementation. Differential gene expression was evaluated in 112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System.

研究设计

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

入排标准

年龄范围
20 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • To pass a recruitment medical examination consisting of a clinical examination and recording the participant's medical history.
  • Non-smoker and not being on a medication regimen.
  • Written informed consent prior to participation.
  • With regard to the sedentary controls, none of the subjects reported at least 150 min·wk-1 of moderate-intensity or 75 min·wk-1 of vigorous-intensity aerobic physical activity necessary for substantial health benefits.
  • With regard to athletes, to be involved in a training regime including both indoor exercise and integrated conditioning exercises in addition to competing in matches on weekends.

排除标准

  • 未提供

研究组 & 干预措施

Control Group

Active Comparator

Sedentary: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months

干预措施: Multicentrum (Dietary Supplement)

Experimental Group

Experimental

Athletes: Multicentrum® 2 months. Subjects maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 2 months

干预措施: Multicentrum (Dietary Supplement)

结局指标

主要结局

Gene expression analysis

时间窗: 6 months

112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System. Relative quantification was determined using the 2-ΔCT method. Cut-off punctuation was established as 1.5.

次要结局

  • Biochemical parameters - Urea(At baseline)
  • Anthropometric assessment - Muscle mass(6 months)
  • Biochemical parameters - Glucose(At baseline)
  • Biochemical parameters - Uric acid(At baseline)
  • Biochemical parameters - Triglycerides(At baseline)
  • Biochemical parameters - Total cholesterol(At baseline)
  • Biochemical parameters - Total proteins(At baseline)
  • Anthropometric assessment - Fat percentage(6 months)
  • Anthropometric assessment - Fat free mass(6 months)
  • Anthropometric assessment - Height(6 months)
  • Anthropometric assessment - Weight(6 months)
  • Anthropometric assessment - BMI(6 months)
  • Biochemical parameters - Creatinine(At baseline)
  • Biochemical parameters - Transferrin(At baseline)
  • Biochemical parameters - Albumin(At baseline)

研究者

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

Elena Planells del Pozo

University Professor

Universidad de Granada

研究点 (2)

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