Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
This is short term cross-over randomized trial including 30 participants. Intervention will consist of the administration of selected food (oranges and Iberian cured-ham). For the short-term cross-ove
Sponsors
University of Valencia
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Between 18 and 50 years old
Exclusion criteria
Exclusion criteria: 1. Diseased 2. Allergic or intolerance to oranges or cured-ham 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 |
|---|---|
| 1. Changes in the expression of genes related to obesity and cardiovascular risk will be measured using RNA isolated from blood at baseline and after intervention (at 4 hours). 1.1. In a subsample, changes in gene expression will be analyzed at the whole transcriptome level by using transcriptome-wide human arrays. The top ranked genes, related to obesity/cardiovascular risk will be selected to analyze their specific gene expression in all the participants by RT-PCR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in fasting glucose and fasting triglycerides will be measured in fasting plasma by standard procedures from baseline to 4 hours. 2. Changes in blood pressure will be measured from baseline to 4 hours post intervention. 3. Weight, height, waist circumference and body composition by bioimpedance will be measured at baseline. 4. Food intake and adherence to the Mediterranean diet will be measured using the 14-item Mediterranean diet adherence PREDIMED scale at baseline. 5. Physical activity will be measured using the short form of the Minnesota physical activity questionnaire at baseline. 6. Sleep characteristics will be measured using the Pittsburgh Sleep Quality Index questionnaire at baseline. 7. Chronotype will be measured using the Horne and Östberg questionnaire at baseline. 8. Metabolic markers of consumption of oranges and cured ham will be measured using plasma and urine samples at baseline and at 4 hours when additional funding is available. | — |
Countries
Spain
Outcome results
None listed