Trial record 12 of 1032 for:    Open Studies | micronutrients

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Universidade do Porto
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto
ClinicalTrials.gov Identifier:
NCT02027675
First received: December 19, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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

Condition Intervention
Asthma
Obesity
Other: High fat poor micronutrient meal
Other: Mediterranean meal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Meal-Exercise Challenge and Physical Activity Reduction Impact on Immunity and Inflammation

Resource links provided by NLM:


Further study details as provided by Universidade do Porto:

Primary Outcome Measures:
  • Airway inflammation [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    1. Lung function before and after challenge and bronchodilator response;
    2. Exhaled nitric oxide;
    3. Exhaled breath condensate (EBC);


Secondary Outcome Measures:
  • Autonomic nervous system response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Rest heart rate; pupillary response, before and after challenge Neuropeptides measurement

  • Oxidative stress biomarkers [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Assessment of plasma F2-isoprostanes, lipid hydroperoxides, protein carbonyls, hydrogen peroxide and lipid soluble antioxidants

  • Circulating blood leukocyte-total and differential leukocyte counts and lymphocyte subpopulations assessment. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Histamine skin test reactivity [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Histamine skin test reactivity, assessed by skin prick test response


Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
Other: Mediterranean meal
The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an Mediterranean meal
Experimental: 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.

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027675

Contacts
Contact: Diana Silva, MD 00351 919 078 179 pdicss11004@med.up.pt
Contact: Rita Moreira 00351 918 447 223 meriitproject@gmail.com

Locations
Portugal
Faculty of Medicine of Porto University Recruiting
Portugal, Porto, Portugal, 4200
Contact: Diana Silva, MD    00351919078179    pdicss11004@med.up.pt   
Contact: Rita Moreira    00351918447223    meriitproject@gmail.com   
Principal Investigator: Diana Silva, MD         
Sub-Investigator: André Moreira, PhD         
Faculty of Nutrition and Food Sciences of the University of Porto Recruiting
Porto, Portugal, 4200
Contact: Rita Moreira    00351 918 447 223    meriitproject@gmail.com   
Principal Investigator: Rita Moreira         
Sub-Investigator: Pedro Moreira, PhD         
Faculty of Sports of Porto University Recruiting
Porto, Portugal, 4200
Contact: Diana Silva, MD    000351919078179    pdicss11004@med.up.pt   
Sub-Investigator: Joana Carvalho, PhD         
Sponsors and Collaborators
Universidade do Porto
Investigators
Principal Investigator: Diana Silva, MD Faculty of Medicine of Porto University
Principal Investigator: Rita Moreira Faculty of Nutrition and Food Sciences of the University of Porto
  More Information

Additional Information:
No publications provided

Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT02027675     History of Changes
Other Study ID Numbers: MERIIT project
Study First Received: December 19, 2013
Last Updated: May 27, 2014
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Universidade do Porto:
exercise
immune function
inflammation
immunity
diet
obesity
asthma

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Inflammation
Obesity
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014