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Dietary HabitsCASSIOPEANCT03119142

Economic Crisis and Adherence to the Mediterranean Diet (CASSIOPEA)

An observational study of Dietary Habits and Inflammation, run by Neuromed IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The socioeconomic gradient in health is well known and is partially explained by differences in health-related behaviours across socioeconomic groups. There is reason to believe that the current economic crisis has been contributing to the observed rapid decrease in the adherence to the Mediterranean diet, thus… Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Dietary Habits, Inflammation, Economic Problems
How many people
3,646 participants
Where
1 siteItaly
Study dates
2 May 2017to 31 Jan 2020
How long will I take part?
6 Months
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: MOLI-SANI is a population-based cohort study that recruited, between 2005 and 2010, 24,325 men and women at random from individuals aged 35 years or older resident in the Molise region, to investigate genetic and environmental risk factors for cardiovascular, cerebrovascular and tumour diseases. Of them, the present study will include about 7,000 subjects recruited in 2005-2006.

Who may be able to join

  • The present study will include subjects recruited in the Moli-sani cohort during 2005-2006 and for which inclusion criteria were:
  • aged >=35 years
  • inscribed in the city hall registries

Who cannot join

  • The present study will include subjects recruited in the Moli-sani cohort during 2005-2006 and for which exclusion criteria were:
  • pregnancy at the time of recruitment,
  • disturbances in understanding or willingness
  • current poly-traumas or coma, refusal to sign the Informed Consent form

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Irccs Neuromed

    Campobasso, 86100

Other trials in Italy

About this study

Official title: Economic Crisis and Adherence to the Mediterranean Diet: Possible Impact on Biomarkers of Inflammation and Metabolic Phenotypes in the Cohort of the MOLI-SANI Study

The socioeconomic gradient in health is well known and is partially explained by differences in health-related behaviours across socioeconomic groups. There is reason to believe that the current economic crisis has been contributing to the observed rapid decrease in the adherence to the Mediterranean diet, thus reducing a protective factor against the development of major chronic diseases. This project aims at investigating whether the economic crisis could account for the shifting from the Mediterranean diet. Additionally, it will address variations in inflammation biomarkers (possibly dietary-related) or metabolic phenotypes as useful biological accounts for the decline in the adherence to Mediterranean diet. This project will also test whether for economically weakest people cultural resources could somehow attenuate the impact of material circumstances on lifestyle changes attributable to the economic crisis.

Read the detailed description

Specific aims:

Aim 1: To identify population groups differently affected by the economic crisis within the population-based cohort of the MOLI-SANI study recruited in the years 2005-2006 (before economic crisis). This aim will be achieved by a new assessment of self-reported economic difficulties possibly emerged after the recruitment.

Aim 2: To estimate possible changes in dietary and health-related behaviours (with particular focus on the adherence to the Mediterranean diet) in subjects identified in the previous aim as highly or poorly affected by the economic crisis. Inflammatory status and metabolic phenotypes will be assessed in the two groups, recalled in a suitable proportion, to establish a possible link between shifting from the Mediterranean diet and adverse health outcomes. Quality of life and stress status will also be evaluated.

Aim 3: To evaluate in the group more affected by economic constraints whether nutrition knowledge and mass media exposure would account for the decline in the adherence to the Mediterranean diet and consequent changes in inflammatory status and/ or metabolic phenotypes.

Experimental Design Aim 1: Aim 1 will identify two groups of subjects as being most or less affected by the economic crisis. This aim will be reached by recall of 7,000 individuals from the Moli-sani cohort recruited in the years 2005-2006. Subjects will be administered a questionnaire to assess economic constraints likely occurred after the economic crisis onset. The questionnaire will update socioeconomic position and estimate economic constraints, food quality and food expenditure.

Experimental Design Aim 2: Within the two groups identified in aim 1, aim 2 will:

  1. Perform a dietary follow up by administering the Italian version of the EPIC questionnaire (9), already used at baseline, to estimate the changes in dietary habits. Lifestyle follow up will be obtained by a validated questionnaire used at baseline.
  2. Assess changes in inflammatory status by measurements of the following biomarkers: High-sensitivity C-reactive protein, Interleukin-6, Interleukin-18, Tumor necrosis factor, Plasminogen activator inhibitor-1, VCAM, ICAM, P-selectin, E-selectin, L-selectin, CD40L, adiponectin, platelet and leukocyte counts, lipids, triglycerides, glucose, insulin.
  3. Estimate variations in the metabolic phenotypes (prevalence of hypertension, diabetes, obesity, metabolic syndrome, and levels of blood pressure, hip and waist circumferences).

Experimental Design Aim 3: A validated questionnaire on nutrition knowledge and exposure to mass media will be administered. This will allow to retrospectively identify additional subgroups differently exposed to information in order to estimate the role of cultural resources in health-related behavioural changes.

Medical subject headings
Feeding Behavior, Inflammation, Obesity, Diabetes Mellitus, Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to the Mediterranean diet

    Dietary information will be collected by administering the Italian version of the EPIC questionnaire (Pala V et al. Tumori. 2003;89:594-607), already used at baseline, to estimate the changes in dietary habits. Adherence to a Mediterranean dietary pattern will be evaluated both by a priori (Mediterranean Diet Score; Trichopoulou A et al. N Engl J Med. 2003;348:2599-608) and a posteriori approach (Principal Factor Analysis; Centritto F et al. Nutr Metab Cardiovasc Dis. 2009;19:697-706).

    Measured: The follow-up is of 10 years since baseline enrolment (2005-2010)

Secondary outcomes (5)

  1. Obesity

    Body mass index (BMI) will be obtained by dividing weight in kilograms (kg) by height (meters) squared. Obesity will be defined according to the following BMI categories: Underweight = <18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater.

    Measured: The follow-up is of 10 years since baseline enrolment (2005-2010)

  2. Hypertension

    Hypertension will be defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg or treatment for hypertension.

    Measured: The follow-up is of 10 years since baseline enrolment (2005-2010)

  3. Hypercholesterolemia

    Hypercholesterolemia will be defined if total cholesterol ≥240 mg/dl or by use of specific medication.

    Measured: The follow-up is of 10 years since baseline enrolment (2005-2010)

  4. Diabetes

    Diabetes will be defined as blood glucose ≥126 mg/dl or by use of specific pharmacological treatment.

    Measured: The follow-up is of 10 years since baseline enrolment (2005-2010)

  5. Inflammation

    Inflammatory status will be assessed by measurements of the following biomarkers: High-sensitivity C-reactive protein, Interleukin-6, Interleukin-18, Tumor necrosis factor, Plasminogen activator inhibitor-1, VCAM, ICAM, P-selectin, E-selectin, L-selectin, CD40L, adiponectin, platelet and leukocyte counts, lipids, triglycerides, glucose, insulin.

    Measured: The follow-up is of 10 years since baseline enrolment (2005-2010)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start2 May 2017
  3. Primary completion31 Jul 2019
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,646 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119142
Sponsor's protocol ID
5/17
Acronym
CASSIOPEA
Status last verified
Sep 2020
First submitted
10 Apr 2017
Last updated
16 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bonaccio M, Costanzo S, Di Castelnuovo A, Persichillo M, De Curtis A, Olivieri M, Cerletti C, Donati MB, de Gaetano G, Iacoviello L; CASSIOPEA Study and Moli-sani Study Investigators. The CASSIOPEA Study (Economic Crisis and Adherence to the Mediterranean diet: poSSIble impact on biOmarkers of inflammation and metabolic PhEnotypes in the cohort of the Moli-sAni Study): Rationale, design and characteristics of participants. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1053-1062. doi: 10.1016/j.numecd.2020.12.008. Epub 2020 Dec 13.

    PubMed 33549444

Questions about this trial

What is this clinical trial studying?

An observational study of Dietary Habits and Inflammation, run by Neuromed IRCCS at 1 site in Italy.

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 16 Sep 2020. 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 Italy. 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?

Adherence to the Mediterranean diet (time frame: The follow-up is of 10 years since baseline enrolment (2005-2010)). 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 NCT03119142, which also lists 1 linked publication.

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 16 Sep 2020.

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