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Meal-Exercise Challenge and Physical Activity Reduction Impact on Immunity and Inflammation (MERIIT)

2015年4月28日 更新者：Universidade do Porto

In a society where exercise is prescribed by physicians to increase physical condition, improve dietary habits and reduce cardiovascular risk, the impact of exercise, acute or chronic, and diet in inflammation and immunity is unknown. Specific populations can have different responses towards acute and chronic exercise. Moreover specific conditions, like the type of meal ingested, can interfere with these responses. The true effect of pre-competitive meal exercise in the immunity and inflammatory response is unknown. Acute physical inactivity periods, commonly happens during daily life, related to work or acute illness. New evidence points out that it induces immediate metabolic and endocrinological changes, these can might also be associated with changes in immune response.

Aims of this project are:

  1. to assess the effect of the precompetitive meal on the inflammatory, neuro-immune and metabolic response to exercise;
  2. to assess the effects of sedentary behaviour on inflammatory, neuro-immune and metabolic response;
  3. to assess differences in changes between healthy, asthmatic and obese subjects

研究概览

地位

完全的

条件

干预/治疗

详细说明

Two interventions will be performed for assessing the research questions and aims:

A) Randomized cross-over, with a wash out period of 7 days, single-blinded trial where two different pre-competitive meals will be followed by an exercise challenge; inflammatory neuro-immune and metabolic response will be assessed before and after each challenge.

Participants will be recruited from advertisement and four different groups will be compared: obese-asthmatic; asthmatic non-obese; obese without asthma and non-asthmatic and non-obese. All patients will be allocated to a meal challenge in which a high fat poor micronutrient meal followed by a Mediterranean meal or vice-versa; meal challenge order will be randomized and participants will be blinded to the intervention. The main outcome for this intervention will be airway inflammation and lung function. All outcomes will be assessed before and 3h after each meal.

A group of individuals will, in the three hours after the meal, perform an exercise challenge, which is aimed to induce acute immune changes.

B) Randomized controlled trial where participants, after a run-in period and eligibility evaluation, will be allocated to an intervention consisting in a reduction of physical activity by 50% or maintaining habitual physical activity for two weeks; inflammatory neuro-immune and metabolic response will be assessed before and after intervention.

研究类型

介入性

注册 (实际的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 葡萄牙
      • Porto、葡萄牙、4200
        • Faculty of Nutrition and Food Sciences of the University of Porto
      • Porto、葡萄牙、4200
        • Faculty of Sports of Porto University
    • Porto
      • Portugal、Porto、葡萄牙、4200
        • Faculty of Medicine of Porto University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • controlled mild to moderate asthma;
  • Body mass index (BMI) ≥ 25 kg/m2; healthy participants (non asthmatic with a BMI 18,5 to 25 kg/m2) will be used for comparison;

Exclusion Criteria:

  • respiratory disease other than asthma;
  • severe asthma according to Global Initiative for Asthma (GINA) guidelines
  • occurrence in previous 4 weeks of screening of upper/lower respiratory tract infection;
  • smoking in the past 6 months and requiring mechanical ventilation for respiratory event within 6 months of screening.
  • Medical conditions (hematologic, cardiovascular, renal, hepatic, neurologic or metabolic) or medication that may interfere with meal or physical activity intervention;
  • Significant chronic infectious diseases (eg, HIV, hepatitis B or C);
  • Abnormal electrocardiogram screening, cardiac arrhythmia, angina, congestive heart failure; renal or hepatic failure and systemic disease, mal-absorption disease history or intestinal inflammatory disease;
  • Women breast-feeding, pregnant or intending pregnancy during study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Meal Exercise Challenge- Order 2
Two different meals,an high fat micronutrient poor meal and Mediterranean Meal will be followed by an exercise challenge and performed at different orders accordingly to the cross over design.
其他：High fat poor micronutrient meal
The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an high fat poor micronutrient meal.
其他：Mediterranean meal
The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an Mediterranean meal
实验性的：Meal Exercise Challenge- Order 1

Two different meals,an high fat micronutrient poor meal and Mediterranean Meal will be followed by an exercise challenge and performed at different orders accordingly to the cross over design.

Each arm corresponds to a different intervention order.
其他：High fat poor micronutrient meal
The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an high fat poor micronutrient meal.
其他：Mediterranean meal
The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an Mediterranean meal

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Airway inflammation
大体时间：Up to 6 months
  1. Lung function before and after challenge and bronchodilator response;
  2. Exhaled nitric oxide;
  3. Exhaled breath condensate (EBC);
Up to 6 months

次要结果测量

结果测量
措施说明
大体时间
Autonomic nervous system response
大体时间：Up to 6 months
Rest heart rate; pupillary response, before and after challenge Neuropeptides measurement
Up to 6 months
Oxidative stress biomarkers
大体时间：Up to 6 months
Assessment of plasma F2-isoprostanes, lipid hydroperoxides, protein carbonyls, hydrogen peroxide and lipid soluble antioxidants
Up to 6 months
Circulating blood leukocyte-total and differential leukocyte counts and lymphocyte subpopulations assessment.
大体时间：Up to 6 months
Evaluated by flow cytometry: T cell (CD4+/CD8+), and their subsets; B cells (CD19+), Natural Killer (NK) cells (CD16+/56+), their subsets; monocytes subsets; oxidative burst activity
Up to 6 months

其他结果措施

结果测量
措施说明
大体时间
Histamine skin test reactivity
大体时间：Up to 6 months
Histamine skin test reactivity, assessed by skin prick test response
Up to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universidade do Porto

调查人员

  • 首席研究员：Diana Silva, MD、Faculty of Medicine of Porto University
  • 首席研究员：Rita Moreira、Faculty of Nutrition and Food Sciences of the University of Porto

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年4月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2014年9月1日

研究注册日期

首次提交

2013年12月19日

首先提交符合 QC 标准的

2014年1月2日

首次发布 (估计)

2014年1月6日

研究记录更新

最后更新发布 (估计)

2015年4月29日

上次提交的符合 QC 标准的更新

2015年4月28日

最后验证

2014年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MERIIT project

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