Cardiovascular risk factors Circulatory System Cardiovascular risk factors
Conditions
Interventions
Centers are cluster randomised using a computer-generated random number sequence to either the intervention or the control group.
The intervention group will receive the Multifactorial
Sponsors
SEAT SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects =18 years 2. Active workers of SEAT company with a theoretical working life =12 months 3. Willingness to follow the multifactorial interventions (diet, physical exercise and emotional health) proposed in the study 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Documented psychiatric disorders (schizophrenia, bipolar disorder, and/or major depression) 2. Allergies or intolerances to the principal components of the Mediterranean diet such as nuts or olive oil 3. Workers who in the opinion of the researcher, consider that they will not follow the recommendations of the study 4. Affected by any of the following circumstances: 4.1. Confirmed gastrointestinal pathology, such as a history of inflammatory bowel disease, malabsorption, or previous bowel surgery (with the exception of appendicitis) 4.2. Confirmed autoimmune pathology 4.3. Strict vegan diet or other types of diets that may difficult the following of the traditional Mediterranean diet 4.4. Previous treatments with antibiotics the month prior to their inclusion in the study 4.5. Liver cirrhosis or confirmed chronic liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following are assessed at the baseline and at the end of the study: 1. Changes in cardiovascular risk measured according to the following risk factors: 1.1. Blood pressure, assessed using a validated semiautomatic oscillometer 1.2. Plasma fasting glucose, assessed using a fasted blood test 1.3. HbA1c, assessed using a fasted blood test 1.4. Total cholesterol, assessed using a fasted blood test 1.5. LDL cholesterol, assessed using a fasted blood test 1.6. HDL cholesterol, assessed using a fasted blood test 1.7. Triglycerides, assessed using a fasted blood test 1.8. Smoking status, assessed by self-report (classified as "current", "former" or "non-smoking") 1.9. Alcohol consumption, assessed by self-report as total grams of ethanol per day 2. Changes in: 2.1. Body weight, measured using a calibrated balance beam scale 2.2. Height, measured using a wall-mounted stadiometer 2.3. Waist circumference, measured using an anthropometric tape 3. Changes in the intestinal microbiome, assessed using microbiota analysis of stool samples | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed at the baseline and at the end of the study: 1. Changes in silent target organ damage: 1.1. Microalbuminuria, assessed by analysing the albumin/creatinine ratio from spot morning urine samples 1.2. Ventricular hypertrophy, assessed using an electrocardiogram 2. Changes in quality of life, assessed using: 2.1. Goldberg Depression Test (Spanish version) 2.2. Wagnild and Young's resilience scale (Spanish version) 3. Changes in Mediterranean Diet adherence, assessed using the PREDIMED score 4. Changes in physical activity and sedentarism, assessed using the International Physical Activity Questionnaire (IPAQ) (Spanish version) 5. Changes in emotional health, assessed using the 25-item item Resilience Scale of Wagnild and Young 6. Association between Mediterranean diet adherence (assessed as per secondary outcome measure 3) and inflammatory biomarkers. Inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), ICAM and VCAM will be assessed using: 6.1. Enhanced immunoturbidimetry 6.2. ELISA 7. Association between inflammatory biomarkers (assessed as per secondary outcome measure 3) and changes in intestinal microbiome (assessed as per primary outcome measure 3) | — |
Countries
Spain
Outcome results
None listed