An interventional study of Mediterranean diet counseling in Lung Diseases, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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
Behavioral: Mediterranean diet counseling
The participants of health centers will carry out the same 5 visits (3 individual visits and 2 phone calls), although no changes are induced in their usual diet and they will not be offered access to the nutritional blog.
The participants of the intervention CAP will enter into an educational program to increase adherence to the DiMet that will integrate three operational components: 1. Explain the particularities of DiMet and the benefits of its monitoring. It will be an individual visit of 25-30 minutes (V1) where the study variables will be collected and the medical tests will be performed and repeated annually for two years (V3 and V5). 2. Clarify the doubts of the DiMet monitoring and the advice received. It will be a telephone visit to reinforce the intervention, with annual frequency, for two years (V2 and V4). 3. Report on DiMet's own foods, cooking habits, adapted recipes and other related topics. It will be for access to an ad hoc designed nutrition blog.
Change in lung function values in smokers without previous respiratory disease
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
Time frame: 2 years
Nutritional intervention
The effectiveness of the intervention will be measured by dietary changes by a food frequency questionnaire
Time frame: 2 years
Nutritional intervention
Adherence to the Mediterranean diet will be measured by dietary changes in a mediterranean diet adherence score of 14-ítem
Time frame: 2 years
Anthropometric parameters
Changes in anthropometric parameters: weight in kilograms and height in meters. Weight and height will be combined to report BMI in kg/m2
Time frame: 2 years
Anthropometric parameters
Changes in anthropometric parameters: abdominal perimeter
Time frame: 2 years
Changes in food consumption markers
Changes in food consumption markers: excreted of total polyphenols in fresh urine.
Time frame: 2 years
Changes in inflammation markers
Changes in serum inflammation markers: high-sensitivity C-reactive protein
Time frame: 2 years
Changes in inflammation markers
Changes in serum inflammation markers: interleukin-6
Time frame: 2 years
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina