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

NCT02027675 | Completed

• 1 other identifier: MERIIT project
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Asthma; Obesity

Keywords

exercise; immune function; inflammation; immunity; diet; obesity; asthma

Outcome Measures

Primary Outcomes (1)

• Airway inflammation

  1. Lung function before and after challenge and bronchodilator response; 2. Exhaled nitric oxide; 3. Exhaled breath condensate (EBC);

  Up to 6 months

Secondary Outcomes (3)

• Autonomic nervous system response

  Up to 6 months

• Oxidative stress biomarkers

  Up to 6 months

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

  Up to 6 months

Other Outcomes (1)

• Histamine skin test reactivity

  Up to 6 months

Study Arms (2)

Meal Exercise Challenge- Order 2

EXPERIMENTAL

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.

Other: High fat poor micronutrient meal; Other: Mediterranean meal

Meal Exercise Challenge- Order 1

EXPERIMENTAL

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.

Other: High fat poor micronutrient meal; Other: Mediterranean meal

Interventions

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.

Meal Exercise Challenge- Order 1; Meal Exercise Challenge- Order 2

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

Meal Exercise Challenge- Order 1; Meal Exercise Challenge- Order 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (3)

Faculty of Nutrition and Food Sciences of the University of Porto

Porto, Porto District, 4200, Portugal

Location

Faculty of Sports of Porto University

Porto, Porto District, 4200, Portugal

Location

Faculty of Medicine of Porto University

Portugal, Porto District, 4200, Portugal

Location

Related Links

• Related Info

MeSH Terms

Conditions

Asthma; Obesity; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes

Study Officials

• Diana Silva, MD

  Faculty of Medicine of Porto University

  PRINCIPAL INVESTIGATOR

• Rita Moreira

  Faculty of Nutrition and Food Sciences of the University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 6, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2014-11

Locations

PT (3)