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Completed

NCT Number: NCT02027675

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nutrition and Food Sciences of the University of Porto, Porto, Porto District, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High fat poor micronutrient meal

Other

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.

Mediterranean meal

Other

The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an Mediterranean meal

Primary outcomes

  1. Airway inflammation

    Time frame: Up to 6 months

    • Lung function before and after challenge and bronchodilator response;
    • Exhaled nitric oxide;
    • Exhaled breath condensate (EBC);

Secondary outcomes

  1. Autonomic nervous system response

    Time frame: Up to 6 months

    Rest heart rate; pupillary response, before and after challenge Neuropeptides measurement

  2. Oxidative stress biomarkers

    Time frame: Up to 6 months

    Assessment of plasma F2-isoprostanes, lipid hydroperoxides, protein carbonyls, hydrogen peroxide and lipid soluble antioxidants

  3. Circulating blood leukocyte-total and differential leukocyte counts and lymphocyte subpopulations assessment.

    Time frame: 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

Other outcomes

  1. Histamine skin test reactivity

    Time frame: Up to 6 months

    Histamine skin test reactivity, assessed by skin prick test response

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Acronym: MERIIT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2014
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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