Lung Diseases Clinical Trial
— MEDISTAROfficial title:
MEDISTAR STUDY: Mediterranean Diet and Smoking in Tarragona and Reus
Verified date | February 2023 |
Source | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 566 |
Est. completion date | July 1, 2020 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 75 Years |
Eligibility | Inclusion Criteria: - Active smoking and cumulative consumption =10 pack-years. - Age between 25-75 years. - Internet connection. Exclusion Criteria: - History of respiratory disease. - Chronic or terminal disorder that alters basal parameters. - Any reason that limits follow up. |
Country | Name | City | State |
---|---|---|---|
Spain | Jordi Gol i Gurina Foundation | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | Preventive Services and Health Promotion Research Network |
Spain,
Catalin RE, Martin-Lujan F, Salamanca-Gonzalez P, Palleja-Millan M, Villalobos F Santigosa-Ayala A, Pedret A, Valls-Zamora RM and Sola R. Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project. N
Martin-Lujan F, Catalin RE, Salamanca-Gonzalez P, Sorli-Aguilar M, Santigosa-Ayala A, Valls-Zamora RM, Martin-Vergara N, Canela-Armengol T, Arija-Val V, Sola-Alberich R. A clinical trial to evaluate the effect of the Mediterranean diet on smokers lung fun — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 years | |
Secondary | Nutritional intervention | The effectiveness of the intervention will be measured by dietary changes by a food frequency questionnaire | 2 years | |
Secondary | Nutritional intervention | Adherence to the Mediterranean diet will be measured by dietary changes in a mediterranean diet adherence score of 14-ítem | 2 years | |
Secondary | 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 | 2 years | |
Secondary | Anthropometric parameters | Changes in anthropometric parameters: abdominal perimeter | 2 years | |
Secondary | Changes in food consumption markers | Changes in food consumption markers: excreted of total polyphenols in fresh urine. | 2 years | |
Secondary | Changes in inflammation markers | Changes in serum inflammation markers: high-sensitivity C-reactive protein | 2 years | |
Secondary | Changes in inflammation markers | Changes in serum inflammation markers: interleukin-6 | 2 years |
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