Pulmonary FunctionDIETNCT02151669
Diet Intervention Spirometry and Tobacco
A study testing Mediterranean Diet in people with Pulmonary Function, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern in lung function in smokers. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Function
- What is being tested?
- Mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Nov 2016
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being active smokers at the time of enrollment with an cumulative consumption more than 10 packs / year
- Having Internet access and regular use of new technologies in general or have help for it.
- Having participated in the first phase of the project: RESET study (PI11/01962).
Who cannot join
- Any evidence of previous diagnosis of respiratory disease,
- Suffering from a terminal or chronic disorder that alters the baseline parameters or hinder the completion of testing and required test during the study period,
- Inability to track for any reason,
- Express refusal of the patient to continue in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF A MEDITERRANEAN DIET INTERVENTION IN PULMONARY FUNCTION IN SMOKERS: A MULTICENTER RANDOMIZED CLINICAL TRIAL IN PRIMARY CARE CENTERS
Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the efficacy of a motivational smoking intervention based on information obtained by spirometry (FIS project PI11/01962).
Read the detailed description
Design: Multicenter randomized controlled trial in primary care. Sample: We will recruit 80 smokers from 35 to 70 years without history of lung disease. Subjects will be randomly assigned to control or intervention group (1:1).
Study variables: We measure socio-demographic, clinical, anthropometry and spirometry data. Food consumption will be evaluated by a semi-quantitative food frequency questionnaire (FFQ), energy expenditure in physical activity by the Minnesota Leisure Time Activity questionnaire and adherence to Mediterranean Diet by a 14-item questionnaire.
Intervention: Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.
Analysis: All analyses will be based on intention-to-treat. The results will be considered clinically relevant when it detects a difference in lung function (decreased FEV1) >10-12 ml/year. A p-value of <0.05 will defined statistical significance.
- Conditions
- Pulmonary Function
- Being tested
- Mediterranean Diet
- Keywords
- Mediterranean diet, Smoking/tobacco, Spirometry
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Group | Experimental | Nutritional intervention to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years. Receives: Behavioral: Mediterranean Diet |
| Control group | No intervention | Participants of control group will be referred to your doctor or nurse with reference to a report on specific according to your personal situation dietary recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lung function
Assess the relationship between lung function and adherence to a Mediterranean Diet and its components
Measured: 2 years
Secondary outcomes (2)
Lung function and anthropometric parameters
Assess the relationship between lung function and anthropometric parameters such as waist circumference and BMI.
Measured: 2 years
Lung function and effectiveness of a nutritional educational tool 2.0
To evaluate the effectiveness of using an nutritional educational tool 2.0 to increase adherence to a Mediterranean diet: blog.
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 posted30 May 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FunctionStudies 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
- Masking
- None (open label)
- Enrolment
- 80 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, MD, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151669
- Sponsor's protocol ID
- 4R13/068
- Acronym
- DIET
- Status last verified
- Feb 2023
- First submitted
- 26 May 2014
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Salamanca-Gonzalez P, Valls-Zamora RM, Pedret-Figuerola A, Sorli-Aguilar M, Santigosa-Ayala A, Catalin RE, Palleja-Millan M, Sola-Alberich R, Martin-Lujan F, The Cenit Research Group Investigators. Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care. Nutrients. 2021 Oct 14;13(10):3597. doi: 10.3390/nu13103597.
PubMed 34684600Sorli-Aguilar M, Martin-Lujan F, Flores-Mateo G, Arija-Val V, Basora-Gallisa J, Sola-Alberich R; RESET Study Group investigators. Dietary patterns are associated with lung function among Spanish smokers without respiratory disease. BMC Pulm Med. 2016 Nov 25;16(1):162. doi: 10.1186/s12890-016-0326-x.
PubMed 27884188Sorli-Aguilar M, Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Flores-Mateo G, Basora-Gallisa J, Arija-Val V, Sola-Alberich R. Effects of mediterranean diet on lung function in smokers: a randomised, parallel and controlled protocol. BMC Public Health. 2015 Jan 31;15:74. doi: 10.1186/s12889-015-1450-x.
PubMed 25636808
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF A MEDITERRANEAN DIET INTERVENTION IN PULMONARY FUNCTION IN SMOKERS: A MULTICENTER RANDOMIZED CLINICAL TRIAL IN PRIMARY CARE CENTERS
- ClinicalTrials.gov ID
- NCT02151669
- Acronym / sponsor ID
- DIET / 4R13/068
- Conditions
- Pulmonary Function
- Keywords
- Mediterranean diet, Smoking/tobacco, Spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 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
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- 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.
Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the efficacy of a motivational smoking intervention based on information obtained by spirometry (FIS project PI11/01962).
Detailed description
Design: Multicenter randomized controlled trial in primary care. Sample: We will recruit 80 smokers from 35 to 70 years without history of lung disease. Subjects will be randomly assigned to control or intervention group (1:1).
Study variables: We measure socio-demographic, clinical, anthropometry and spirometry data. Food consumption will be evaluated by a semi-quantitative food frequency questionnaire (FFQ), energy expenditure in physical activity by the Minnesota Leisure Time Activity questionnaire and adherence to Mediterranean Diet by a 14-item questionnaire.
Intervention: Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.
Analysis: All analyses will be based on intention-to-treat. The results will be considered clinically relevant when it detects a difference in lung function (decreased FEV1) >10-12 ml/year. A p-value of <0.05 will defined statistical significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Group | Experimental | Behavioral: Mediterranean DietNutritional intervention to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years. |
| Control group | No intervention | –Participants of control group will be referred to your doctor or nurse with reference to a report on specific according to your personal situation dietary recommendations. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being active smokers at the time of enrollment with an cumulative consumption more than 10 packs / year
- Having Internet access and regular use of new technologies in general or have help for it.
- Having participated in the first phase of the project: RESET study (PI11/01962).
Key exclusion criteria (4 listed)
- Any evidence of previous diagnosis of respiratory disease,
- Suffering from a terminal or chronic disorder that alters the baseline parameters or hinder the completion of testing and required test during the study period,
- Inability to track for any reason,
- Express refusal of the patient to continue in the study
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 DietNutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years. | Behavioural | Mediterranean Diet Group |
Primary outcome
Changes in lung function
Time frame: 2 years
Assess the relationship between lung function and adherence to a Mediterranean Diet and its components
2 secondary outcomes
Lung function and anthropometric parameters
Time frame: 2 years
Lung function and effectiveness of a nutritional educational tool 2.0
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 27 Feb 2023.
- Results publication: PubMed 34684600Salamanca-Gonzalez P, Valls-Zamora RM, Pedret-Figuerola A, Sorli-Aguilar M, Santigosa-Ayala A, Catalin RE, Palleja-Millan M, Sola-Alberich R, Martin-Lujan F, The Cenit Research Group Investigators. Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care. Nutrients. 2021 Oct 14;13(10):3597. doi: 10.3390/nu13103597.
- Results publication: PubMed 27884188Sorli-Aguilar M, Martin-Lujan F, Flores-Mateo G, Arija-Val V, Basora-Gallisa J, Sola-Alberich R; RESET Study Group investigators. Dietary patterns are associated with lung function among Spanish smokers without respiratory disease. BMC Pulm Med. 2016 Nov 25;16(1):162. doi: 10.1186/s12890-016-0326-x.
- Derived from this study: PubMed 25636808Sorli-Aguilar M, Martin-Lujan F, Santigosa-Ayala A, Pinol-Moreso JL, Flores-Mateo G, Basora-Gallisa J, Arija-Val V, Sola-Alberich R. Effects of mediterranean diet on lung function in smokers: a randomised, parallel and controlled protocol. BMC Public Health. 2015 Jan 31;15:74. doi: 10.1186/s12889-015-1450-x.
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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, MD 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 in people with Pulmonary Function, 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 4 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 27 Feb 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?
Changes in lung function (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 NCT02151669, which also lists 3 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 27 Feb 2023.