General population (smokers and non-smokers) Not Applicable
Conditions
Interventions
In this randomized and controlled cross-over trial, the same person will receive both interventions (randomly allocated using the appropriate online tool to receive fruit or the control group). The in
Sponsors
University of Valencia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. White European subjects (men and women) recruited from the Mediterranean population 2. Age ranging from 18 to 75 years old 3. BMI <40 Kg/m2
Exclusion criteria
Exclusion criteria: 1. Diabetic subjects 2. Other chronic diseases (cardiovascular, cancer, respiratory diseases, liver diseases, kidney diseases, etc) 3. Subjects with food allergies or food intolerances 4. Alcohol abuse or addiction 5. Immunodeficiency, HIV-positive status, COVID-19 positive status or other acute infections 6. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc 7. Any severe co-morbid condition 8. History of major organ transplantation 9. Concurrent therapy with immunosuppressive drugs or cytotoxic agents 10. Current treatment with systemic corticosteroids 11. Current use of weight loss medication 12. Any other condition that may interfere with the completion of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative methylation profiles (% of DNA-methylated cytosines) in DNA isolated from blood leukocytes measured using arrays and for selected CpG sites by Massarray, according to the standard protocols, at baseline and after one week of the corresponding intervention (frequent consumption of provided fruit or control group without the supplied fruit). DNA will be isolated by standard procedures and quality control measures will be carried out. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma glucose and biochemical parameters (lipids) measured using standard procedures at baseline and after one-week interventions in both groups 2. Height, weight, waist circumference and body composition by bioimpedance measured using validated methods at baseline and after one-week interventions 3. Blood pressure and heart rate measured using standard protocols at baseline and after one-week interventions in both groups 4. Analysis of differential methylation pathways in the whole sample and by sex measured using computer tools 5. Food intake measured using food frequency questionnaires and adherence to the Mediterranean diet measured using a validated scale at baseline 6. Sleep duration, sleep quality and chronotype measured using the Horne and Östberg questionnaire at baseline 7. Additional analysis (depending on the budget) of plasma metabolites (lipids, amino acids, inflammatory markers measured using a standard high-throughput nuclear magnetic resonance metabolomics platform) at baseline and after the one week of the interventions 8. The habit of tobacco consumption will be self-reported by the participants themselves, at baseline and one week for each intervention | — |
Countries
Spain
Outcome results
None listed