Short-term fasting Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a short-term cross-over intervention trial in 25 participants (including men and women). Two interventions related to food consumption will be carried out. All participants will receive both i
Sponsors
University of Valencia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/07/2022: 1. White European subjects (men and women) recruited from the Mediterranean population 2. Age ranging from 18 to 50 years old 3. BMI between 21 and 34 kg/m² _____ Previous inclusion criteria: 1. White European subjects (men and women) recruited from the Mediterranean population 2. Age ranging from 18 to 50 years old 3. BMI between 23 and 33 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 genome-wide gene expression and methylation profiles in leukocytes (using DNA and RNA isolated from blood) to identify transcriptome and methylome signatures (detection of differentially expressed genes and DNA methylation sites) of 24-h fasting versus frequent food consumption after both interventions in healthy subjects from a Mediterranean population. Blood samples will be obtained at baseline and after 24 h of the corresponding intervention (fasting or food consumption). RNA and DNA will be isolated by standard procedures and quality control measures will be carried out. Transcriptome-wide human arrays will be used to analyze differential gene expression and RT-PCR will be used for validation. Methylation will be analyzed by arrays and for selected CpG sites by Massarray according to the standard protocols. Differential gene expression and CpG methylation sites will be statistically analyzed and the combination of the most relevant differentially expressed genes and DNA-methylation sites will be combined by computational analyses to build specific signatures for each intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma glucose and biochemical parameters (lipids) measured by standard procedures at baseline, at 6 h and after the 24 h interventions in both groups 2. Height, weight, waist circumference and body composition by bioimpedance measured by validated methods at baseline and after the interventions 3. Blood pressure and heart rate measured by standard protocols at baseline and after 24 h intervention in both groups 4. Selected gene expression (from the genome-wide transcriptome array) measured by RT-PCR at baseline, at 6 h and after the 24 h interventions 5. Selected DNA methylation measured by MASSARRAY at baseline, 6 h and 24 h after interventions 6. Analysis of differentially expressed genes, methylation sites and pathways (GO and KEEG) at baseline and after interventions in the whole sample and by sex/gender 7. Food intake (assessed with food frequency questionnaires) and adherence to the Mediterranean diet (measured by the 14-item score for adherence) at baseline 8. Physical activity measured using the short form of the Minnesota physical activity questionnaire at baseline 9. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire and the Epworth questionnaires at baseline 10. Chronotype measured using the Horne and Östberg questionnaire at baseline 11. Additional analysis (depending on the budget) of plasma/urine metabolites (lipids, amino acids, inflammatory markers measured using a standard high-throughput nuclear magnetic resonance metabolomics platform) at baseline and after the interventions | — |
Countries
Spain
Outcome results
None listed