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临床试验/NCT03515642
NCT03515642撤回不适用

Effect of Two Exercise Programme on Gut Microbiota, Hepatic Metabolism and Adipokines in Sedentary Adults With Overweight

Universidad Santo Tomas1 个研究点 分布在 1 个国家开始时间: 2018年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Plasma metabolomic profile

研究概览

简要总结

This project offers the opportunity to obtain detailed measurements on the health of body composition, metabolic health, and intestinal microbial diversity in overweight adults; moreover to provide information about the effects of physical exercise on them. The aim of the research is to advance in the understanding of the mechanisms induced by physical exercise, which includes the measurement of nutritional parameters, clinical and biochemical biomarkers of hepatic/cardiometabolic health, as well as the application of differential proteomics technologies by means of Arrays of cytokines and intestinal microbiome, making this study a novel and pioneer in sensitive areas of primary health care in Latin America.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Sedentary males
  • •BMI>25 kg/m2, on a stable body weight for the last 3 months

排除标准

  • •Acute or chronic illness
  • •Use of antibiotics the past 2 months

研究组 & 干预措施

HIIT group

Experimental

The HIIT modality consisted of 30-40 minutes (min) of steady-state, high-intensity training 3 d/wk on a stationary bicycle at the target heart rate (HR) range equivalent to 85% to 95% of the individual's maximum oxygen consumption rate (VO2max). Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6-weeks.

干预措施: HIIT group (Behavioral)

SIT group

Active Comparator

The SIT modality consisted of 6 to 10 repetitions of a 30 s segment of all-out exercise interspersed with 2 min of recovery, 3 d/wk on a stationary bicycle at the target heart rate (HR) range equivalent to 90% to 95% of the individual's maximum oxygen consumption rate (VO2max).

干预措施: HIIT group (Behavioral)

结局指标

主要结局

Plasma metabolomic profile

时间窗: Baseline, and 6 weeks immediately after the interventions ends

Change from Baseline in the metabolomic profile will be also evaluated by a HPLC-MS approach

Gut microbiota

时间窗: Baseline, and 6 weeks immediately after the interventions ends

Change from Baseline in the gut microbiota composition measured by amplicon sequencing

次要结局

  • Physical fitness(Baseline, and 6 weeks immediately after the interventions ends)
  • Plasma hepatokines(Baseline, and 6 weeks immediately after the interventions ends)
  • Bioinflammatory blood markers(Baseline, and 6 weeks immediately after the interventions ends)
  • Body composition(Baseline, and 6 weeks immediately after the interventions ends)
  • Glucose(Baseline, and 6 weeks immediately after the interventions ends)
  • Insulin(Baseline, and 6 weeks immediately after the interventions ends)
  • Energy substrate oxidation(Baseline, and 6 weeks immediately after the interventions ends)
  • Resting Metabolic Rate(Baseline, and 6 weeks immediately after the interventions ends)
  • Glycated hemoglobin(Baseline, and 6 weeks immediately after the interventions ends)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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