AsthmaMERIITNCT02027675
Meal-Exercise Challenge and Physical Activity Reduction Impact on Immunity and Inflammation
A study testing High fat poor micronutrient meal and Mediterranean meal in people with Asthma and Obesity, run by Universidade do Porto at 3 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- High fat poor micronutrient meal and Mediterranean meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesPortugal
- Study dates
- Apr 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Faculty of Nutrition and Food Sciences of the University of Porto
Porto, Porto District, 4200
Faculty of Sports of Porto University
Porto, Porto District, 4200
Faculty of Medicine of Porto University
Portugal, Porto District, 4200
About this study
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:
- to assess the effect of the precompetitive meal on the inflammatory, neuro-immune and metabolic response to exercise;
- to assess the effects of sedentary behaviour on inflammatory, neuro-immune and metabolic response;
- to assess differences in changes between healthy, asthmatic and obese subjects
Read the detailed description
Two interventions will be performed for assessing the research questions and aims:
- 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.
- 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.
- Being tested
- High fat poor micronutrient meal, Mediterranean meal
- Keywords
- exercise, immune function, inflammation, immunity, diet, obesity, asthma
- Medical subject headings
- Asthma, Obesity, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat poor micronutrient mealOther
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 mealOther
The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an Mediterranean meal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High fat poor micronutrient meal; Other: Mediterranean meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway inflammation
- Lung function before and after challenge and bronchodilator response;
- Exhaled nitric oxide;
- Exhaled breath condensate (EBC);
Measured: Up to 6 months
Secondary outcomes (3)
Autonomic nervous system response
Rest heart rate; pupillary response, before and after challenge Neuropeptides measurement
Measured: Up to 6 months
Oxidative stress biomarkers
Assessment of plasma F2-isoprostanes, lipid hydroperoxides, protein carbonyls, hydrogen peroxide and lipid soluble antioxidants
Measured: Up to 6 months
Circulating blood leukocyte-total and differential leukocyte counts and lymphocyte subpopulations assessment.
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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Silva, MD, Principal investigator, Faculty of Medicine of Porto UniversityRita Moreira, Principal investigator, Faculty of Nutrition and Food Sciences of the University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027675
- Sponsor's protocol ID
- MERIIT project
- Acronym
- MERIIT
- Status last verified
- Nov 2014
- First submitted
- 19 Dec 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meal-Exercise Challenge and Physical Activity Reduction Impact on Immunity and Inflammation
- ClinicalTrials.gov ID
- NCT02027675
- Acronym / sponsor ID
- MERIIT / MERIIT project
- Keywords
- exercise, immune function, inflammation, immunity, diet, obesity, asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to assess the effect of the precompetitive meal on the inflammatory, neuro-immune and metabolic response to exercise;
- to assess the effects of sedentary behaviour on inflammatory, neuro-immune and metabolic response;
- to assess differences in changes between healthy, asthmatic and obese subjects
Detailed description
Two interventions will be performed for assessing the research questions and aims:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal Exercise Challenge- Order 2 | Experimental | Other: High fat poor micronutrient meal, Other: Mediterranean mealTwo 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. |
| Meal Exercise Challenge- Order 1 | Experimental | Other: High fat poor micronutrient meal, Other: Mediterranean mealTwo 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fat poor micronutrient mealThe 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 | Meal Exercise Challenge- Order 1, Meal Exercise Challenge- Order 2 |
| Mediterranean mealThe meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an Mediterranean meal | Other | Meal Exercise Challenge- Order 1, Meal Exercise Challenge- Order 2 |
Primary outcome
Airway inflammation
Time frame: Up to 6 months
1. Lung function before and after challenge and bronchodilator response; 2. Exhaled nitric oxide; 3. Exhaled breath condensate (EBC);
3 secondary outcomes
Autonomic nervous system response
Time frame: Up to 6 months
Oxidative stress biomarkers
Time frame: Up to 6 months
Circulating blood leukocyte-total and differential leukocyte counts and lymphocyte subpopulations assessment.
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Silva, MD principal investigator
Faculty of Medicine of Porto University
Rita Moreira principal investigator
Faculty of Nutrition and Food Sciences of the University of Porto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat poor micronutrient meal and Mediterranean meal in people with Asthma and Obesity, run by Universidade do Porto at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway inflammation (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.