Lung DiseasesMEDISTARNCT03362372
Effect of the Mediterranean Diet on Lung Function in Smokers Without Previous Respiratory Disease
A study testing Mediterranean diet counseling in people with Lung Diseases, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Mediterranean diet counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active smoking and cumulative consumption ≥10 pack-years.
- Age between 25-75 years.
- Internet connection.
Who cannot join
- History of respiratory disease.
- Chronic or terminal disorder that alters basal parameters.
- Any reason that limits follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MEDISTAR STUDY: Mediterranean Diet and Smoking in Tarragona and Reus
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.
Read more
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.
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- Mediterranean diet counseling
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING | Experimental | 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 Receives: Behavioral: Mediterranean diet counseling |
| CONTROL GROUP: WITHOUT CHANGES IN DIET | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (7)
Nutritional intervention
The effectiveness of the intervention will be measured by dietary changes by a food frequency questionnaire
Measured: 2 years
Nutritional intervention
Adherence to the Mediterranean diet will be measured by dietary changes in a mediterranean diet adherence score of 14-ítem
Measured: 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
Measured: 2 years
Anthropometric parameters
Changes in anthropometric parameters: abdominal perimeter
Measured: 2 years
Changes in food consumption markers
Changes in food consumption markers: excreted of total polyphenols in fresh urine.
Measured: 2 years
Changes in inflammation markers
Changes in serum inflammation markers: high-sensitivity C-reactive protein
Measured: 2 years
Changes in inflammation markers
Changes in serum inflammation markers: interleukin-6
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, parallel, multicenter, cluster-randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Responsible party
- Sponsor
- Investigators
- Francisco Martín Luján, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362372
- Sponsor's protocol ID
- SLT002/16/00155
- Acronym
- MEDISTAR
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2017
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 function. NPJ Prim Care Respir Med. 2019 Nov 27;29(1):40. doi: 10.1038/s41533-019-0153-7.
PubMed 31776344Catalin RE, Martin-Lujan F, Salamanca-Gonzalez P, Palleja-Millan M, Villalobos F, Santigosa-Ayala A, Pedret A, Valls-Zamora RM, Sola R, On Behalf Of The Medistar Research Group Investigators. Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project. Nutrients. 2023 Mar 3;15(5):1272. doi: 10.3390/nu15051272.
PubMed 36904270
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEDISTAR STUDY: Mediterranean Diet and Smoking in Tarragona and Reus
- ClinicalTrials.gov ID
- NCT03362372
- Acronym / sponsor ID
- MEDISTAR / SLT002/16/00155
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled, parallel, multicenter, cluster-randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING | Experimental | Behavioral: Mediterranean diet counselingDuring 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 |
| CONTROL GROUP: WITHOUT CHANGES IN DIET | No intervention | –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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active smoking and cumulative consumption ≥10 pack-years.
- Age between 25-75 years.
- Internet connection.
Key exclusion criteria (3 listed)
- History of respiratory disease.
- Chronic or terminal disorder that alters basal parameters.
- Any reason that limits follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean diet counselingThe 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. | Behavioural | INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING |
Primary outcome
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
7 secondary outcomes
Nutritional intervention
Time frame: 2 years
Nutritional intervention
Time frame: 2 years
Anthropometric parameters
Time frame: 2 years
Anthropometric parameters
Time frame: 2 years
Changes in food consumption markers
Time frame: 2 years
Changes in inflammation markers
Time frame: 2 years
Changes in inflammation markers
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Results publication: PubMed 31776344Martin-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 function. NPJ Prim Care Respir Med. 2019 Nov 27;29(1):40. doi: 10.1038/s41533-019-0153-7.
- Results publication: PubMed 36904270Catalin RE, Martin-Lujan F, Salamanca-Gonzalez P, Palleja-Millan M, Villalobos F, Santigosa-Ayala A, Pedret A, Valls-Zamora RM, Sola R, On Behalf Of The Medistar Research Group Investigators. Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project. Nutrients. 2023 Mar 3;15(5):1272. doi: 10.3390/nu15051272.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Martín Luján principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet counseling in people with Lung Diseases, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung function values in smokers without previous respiratory disease (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362372, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.