We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03362372
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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: 750 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.


Condition or disease Intervention/treatment
Lung Diseases Behavioral: Mediterranean diet counseling

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: 750 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Controlled, parallel, multicenter, cluster-randomized clinical trial.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: MEDISTAR STUDY: Mediterranean Diet and Smoking in Tarragona and Reus
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: INTERVENTION GROUP: 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
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:

  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.
No Intervention: CONTROL GROUP: WITHOUT CHANGES IN DIET
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.



Primary Outcome Measures :
  1. Change in lung function values in smokers without previous respiratory disease [ Time Frame: 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 :
  1. Nutritional intervention [ Time Frame: 2 years ]
    The effectiveness of the intervention will be measured by dietary changes by a food frequency questionnaire

  2. Nutritional intervention [ Time Frame: 2 years ]
    Adherence to the Mediterranean diet will be measured by dietary changes in a mediterranean diet adherence score of 14-ítem

  3. Anthropometric parameters [ Time Frame: 2 years ]
    Changes in anthropometric parameters: weight in kilograms and height in meters. Weight and height will be combined to report BMI in kg/m2

  4. Anthropometric parameters [ Time Frame: 2 years ]
    Changes in anthropometric parameters: abdominal perimeter

  5. Changes in food consumption markers [ Time Frame: 2 years ]
    Changes in food consumption markers: excreted of total polyphenols in fresh urine.

  6. Changes in inflammation markers [ Time Frame: 2 years ]
    Changes in serum inflammation markers: high-sensitivity C-reactive protein

  7. Changes in inflammation markers [ Time Frame: 2 years ]
    Changes in serum inflammation markers: interleukin-6



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362372


Contacts
Contact: Pau Moreno +34 93 482 45 72 pmoreno@idiapjgol.org

Locations
Spain
Jordi Gol i Gurina Foundation Recruiting
Barcelona, Spain, 08007
Principal Investigator: Francisco Martín-Luján, MD         
Sub-Investigator: Rosa Solà-Alberich, MD         
Sub-Investigator: M Victoria Arija-Val, MD         
Sub-Investigator: Nuria Martín-Vergara, MD         
Sub-Investigator: Mar Sorlí-Aguilar         
Sub-Investigator: Rosa Maria Valls-Zamora         
Sub-Investigator: Antoni Santigosa-Ayala         
Sub-Investigator: Roxana-Elena Catalin         
Sub-Investigator: m Teresa Canela-Armengol         
Sub-Investigator: Patricia Salamanca-González         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
Investigators
Principal Investigator: Francisco Martín Luján Catalan Institute of Health
  Study Documents (Full-Text)

Documents provided by Jordi Gol i Gurina Foundation:

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03362372     History of Changes
Other Study ID Numbers: SLT002/16/00155
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases