Prevention of intermediate chronic disease phenotypes in the general population Not Applicable
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers recruited from the general population 2. Adults between 18 and 60 years old 3. BMI between 20 and 33 kg/m² 4. Habitual good sleepers (7-9 h/nights) 5. Intermediate chronotype
Exclusion criteria
Exclusion criteria: 1. Does not meet the inclusion criteria 2. Shift or rotating workers 3. Travelers across time zones during the month prior to the start of the study 4. Present the following situations: consumption of drugs and alcohol on a regular basis, treatment with anxiolytics, corticosteroids or hypnotics, pregnant women, lactating women or with hormonal treatment, infectious, neurological, psychological, renal or hepatic diseases, cancer or other relevant pathologies that could bias the study 5. Any other condition that may interfere with sleep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression level (Clariom™ S Assays Human and RT-PCR) and methylation pattern measured using (Methylation EPIC 850K array and MALDI-TOF) after a sleep restriction period plus a weekend catch-up period compared to habitual sleep at baseline, 5 and 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biochemical measurements (glucose, cholesterol, triglycerides and inflammatory markers), hormones and metabolites measured in fasting plasma by standard procedures at baseline, 5 and 7 days in both phases 2. Blood pressure measured using an automatic sphygmomanometer (OMRON HEM-705CP)] at baseline, 5 and 7 days in both interventions 3. Weight, waist circumference and body composition by bioimpedance measured at baseline, 5 and 7 days in both phases 4. Food intake, food timing using a phone application and adherence to the Mediterranean diet, measured using the 14-item Mediterranean diet adherence PREDIMED scale at baseline, 5 and 7 days in both phases 5. Physical activity measured using the short form of the Minnesota and RAPA physical activity questionnaire and an actigraph wGT3X-BT model at baseline, 5 and 7 days in both phases 6. Sleep characteristics measured using the Pittsburgh Sleep Quality Index questionnaire, Epworth and actigraph wGT3X-BT model at baseline, 5 and 7 days in both interventions 7. Taste and odor perception using a validated test at baseline, day 5 of sleep restriction and day 7 after the weekend catch-up sleep period 8. Chronotype measured using the Horne and Östberg questionnaire at baseline | — |
Countries
Spain