Effect of the Mediterranean Diet on Lung Function in Smokers Without Previous Respiratory Disease
- Conditions
- Lung Diseases
- Interventions
- Behavioral: Mediterranean diet counseling
- Registration Number
- NCT03362372
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Brief Summary
Several studies have shown the influence of the eating pattern on lung function. However, the benefits of the Mediterranean diet (DiMet) in preventing pulmonary dysfunction are not well known.
Objective: To evaluate the effect of adherence to DiMet on the deterioration of lung function in smokers.
Methodology: Design: Controlled, parallel, multicenter, cluster-randomized clinical trial. Participants: 566 active smokers with a cumulative consumption of more than 10 packets a year, within 25 to 75 year-old age group, without previous respiratory disease and who agree with the conditions of the study and sign an informed consent . Scope: 20 Primary Care Centers managed by the Catalan Health Institutes in Tarragona that will be randomly assigned to a control or an intervention group (1: 1). Intervention: During 2 years a nutritional intervention will be carried out to increase adherence to DiMet based on: 1) annual visit of personalized nutritional education, 2) annual telephone contact for intervention reinforcement, and 3) computer access to a dietary block designed ad hoc. The control group will follow their usual diet style. All participants will receive advice to quit smoking. It will be evaluated: a) pulmonary function by forced spirometry and b) adherence to the DiMet with a questionnaire of 14 items and biological determinations. Statistical analysis: For intention to treat. The unit of analysis will be the individual smoker. Parameters of pulmonary function and adherence to the DiMet of both groups will be compared.
Expected results: DiMet prevents the appearance of altered lung function in smokers without previous respiratory pathology. Thus, DiMet will be key in pulmonary prevention, together with the fundamental recommendation of smoking cessation.
- Detailed Description
Several studies have shown the influence of the eating pattern on lung function. However, the benefits of the Mediterranean diet (DiMet) in preventing pulmonary dysfunction are not well known.
Objective: To evaluate the effect of adherence to DiMet on the deterioration of lung function in smokers.
Methodology: Design: Controlled, parallel, multicenter, cluster-randomized clinical trial. Participants: 566 active smokers with a cumulative consumption of more than 10 packets a year, within 25 to 75 year-old age group, without previous respiratory disease and who agree with the conditions of the study and sign an informed consent . Scope: 20 Primary Care Centers managed by the Catalan Health Institutes in Tarragona that will be randomly assigned to a control or an intervention group (1: 1). Intervention: During 2 years a nutritional intervention will be carried out to increase adherence to DiMet based on: 1) annual visit of personalized nutritional education, 2) annual telephone contact for intervention reinforcement, and 3) computer access to a dietary block designed ad hoc. The control group will follow their usual diet style. All participants will receive advice to quit smoking. It will be evaluated: a) pulmonary function by forced spirometry and b) adherence to the DiMet with a questionnaire of 14 items and biological determinations. Statistical analysis: For intention to treat. The unit of analysis will be the individual smoker. Parameters of pulmonary function and adherence to the DiMet of both groups will be compared.
Expected results: DiMet prevents the appearance of altered lung function in smokers without previous respiratory pathology. Thus, DiMet will be key in pulmonary prevention, together with the fundamental recommendation of smoking cessation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 566
- Active smoking and cumulative consumption ≥10 pack-years.
- Age between 25-75 years.
- Internet connection.
- History of respiratory disease.
- Chronic or terminal disorder that alters basal parameters.
- Any reason that limits follow up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING Mediterranean diet counseling During 2 years a nutritional intervention will be carried out to increase adherence to DiMet based on: annual visit of personalized nutritional education, a telephone contact for intervention reinforcement and computer access to a nutrition blog
- Primary Outcome Measures
Name Time Method Change in lung function values in smokers without previous respiratory disease 2 years Changes in lung function measured by spirometry. An altered lung function was considered if values of FVC \<80% and / or FEV1 \<80% and / or FEV1 / FVC \<0.7
- Secondary Outcome Measures
Name Time Method Nutritional intervention 2 years Adherence to the Mediterranean diet will be measured by dietary changes in a mediterranean diet adherence score of 14-ítem
Changes in inflammation markers 2 years Changes in serum inflammation markers: interleukin-6
Anthropometric parameters 2 years Changes in anthropometric parameters: abdominal perimeter
Changes in food consumption markers 2 years Changes in food consumption markers: excreted of total polyphenols in fresh urine.
Trial Locations
- Locations (1)
Jordi Gol i Gurina Foundation
🇪🇸Barcelona, Spain