Cardiometabolic risk and aging Not Applicable
Conditions
Interventions
Participants will be randomized into three groups (1:1:2) by simple random assignment through a computer program. Therefore, 20, 20 and 40 subjects will be randomized to the intervention group A, inte
Sponsors
University of Valencia
Importaco
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteers recruited from the general population 2. Between 25 and 50 years old 3. BMI between 23 and 35 kg/m2
Exclusion criteria
Exclusion criteria: 1. Diseased 2. Nut allergy or intolerance 3. Immunodeficiency or HIV-positive status 4. Liver cirrhosis or chronic renal failure 5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc 6. Any severe co-morbid condition 7. Alcohol abuse or addition 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. Patients with an acute infection or inflammation 13. Any other condition that may interfere with the completion of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All the outcome measures will be measured at baseline and after 2 months. In addition, for the primary outcomes and for the main secondary outcomes, measures after the 10 months of follow-up will be obtained. 1. Cardiovascular risk parameters measured as follows: 1.1. Anthropometric: including weight, height, waist circumference and body composition, measured by validated scales and bioimpedance 1.2. Blood pressure: systolic and diastolic blood pressure measured by trained personnel with a validated semiautomatic oscillometer using standard procedures 1.3. Fasting glucose, total colesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, liver and kidney enzymes, CRP and leptin measured in fasting plasma samples by standard procedures 1.4. DNA methylation measured in isolated DNA from blood by standard procedures using the SequenomMassARRAY platform or similar. Biological age calculated based on the methylation pattern according to standard procedures | — |
Secondary
| Measure | Time frame |
|---|---|
| All the outcome measures will be measured at baseline and after 2 months. In addition, for the primary outcomes and for the main secondary outcomes, measures after the 10 months of follow-up will be obtained. 1. Dietary patterns measured by validated questionnaires including the 14-item Mediterranean diet adherence score and the 17-item Mediterranean diet score, as well as by food frequency questionnaires 2. Inflammatory markers measured in blood by ELISA and other validated methods 3. Quality of life measured by validated questionnaires (SF-12) 4. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire 5. Physical activity measured using the short form of the Minnesota physical activity questionnaire 6. Chronotype measured using the Horne and Östberg questionnaire 7. Cognitive performance measured using some cognitive tests, including TMT-A, TMT-B, COWAT 8. Metabolomic markers measured in plasma depending on additional funding. RNM will be used in a multimarker platform 9. Gene expression: depending on additional funding selected gene-expression or whole transcriptome gene expression will be measured by RT-PCR or whole transcriptome human arrays | — |
Countries
Spain
Outcome results
None listed