Effect of the Mediterranean Diet on Lung Function in Smokers Without Previous Respiratory Disease

Lung Diseases Clinical Trial

— MEDISTAR  

Official title:

MEDISTAR STUDY: Mediterranean Diet and Smoking in Tarragona and Reus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362372
• Other study ID #: SLT002/16/00155
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2023
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Behavioral:
• Mediterranean diet counseling
The participants of the intervention CAP will enter into an educational program to increase adherence to the DiMet that will integrate three operational components: 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). 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). 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.

Locations

Country	Name	City	State
Spain	Jordi Gol i Gurina Foundation	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Preventive Services and Health Promotion Research Network

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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

Outcome

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