Sleep Wake Disorders
Conditions
Interventions
To determine the sample, a repeated measures test (ANOVA) was considered among the six participant groups of the study, with two measurements (before and after the intervention), an effect size of 30%
Sponsors
Faculdade de Saúde Pública da Universidade de São Paulo
Hospital Alemão Oswaldo Cruz
Eligibility
Sex/Gender
Female
Age
38 Years to No maximum
Inclusion criteria
Inclusion criteria: Women; Age from 38 years old who are in the perimenopause period; Work for at least six months in the current work shift; Declare that they do not intend to change their eating habits, that is, they do not intend to adhere to calorie-restricted diets, food groups and/or meal times. Also declare that you do not intend to modify the physical activities, and these should be maintained during the study, not starting new ones, nor pausing those that are already carried out.
Exclusion criteria
Exclusion criteria: Women who undergo hormone replacement therapy; Pregnant women; Lactating; Mothers with children under 1 year old; Have a second night shift work; Abusive use of drugs and/or alcohol; Make regular use of medications or supplements that influence sleep, alertness and the circadian timing system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of exogenous melatonin on climacteric syndrome using the Kupperman menopausal index questionnaire and hormonal concentrations (estradiol, follicle-stimulating hormone and luteinizing hormone) present in the blood test. It is expected to find an improvement in climacteric symptoms after 3 months of intervention with melatonin.;To assess blood pressure and arterial stiffness using the Arteris method. It is expected to find a reduction in PWV (pulse wave velocity) after 3 months of melatonin administration. ;To assess insomnia symptoms, assessed by the Insomnia Severity Index. It is expected to find a reduction in insomnia symptoms after 3 months of melatonin administration.;To evaluate the effects of exogenous melatonin on psychological symptoms in middle-aged night workers using the DASS-21 questionnaire (depression, anxiety and stress scale). It is expected to find improvement in symptoms of stress, anxiety and depression after 3 months of intervention with melatonin.;To evaluate the effects of exogenous melatonin on sleep quality in middle-aged night workers using the Pittsburgh Questionnaire (PSQI). It is expected to find an improvement in sleep quality after 3 months of intervention with melatonin.;To assess metabolic parameters such as blood glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, serum triglycerides and glycated hemoglobin assessed by blood test. It is expected to find an improvement in metabolic parameters after 3 months of melatonin administration.;It is expected to find an improvement in the quality of the diet, selected through the 24-hour food diary and the food frequency questionnaire, based on the best adequacy in the consumption of macronutrients after the administration of exogenous melatonin.;Evaluate the meal schedule (first and last of the day), verified through a 24-hour food diary, examine the timing of food intake. Based on the reported meal times, to evaluate the variation in pre- a | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate body composition, verified through bioimpedance, and an improvement in body fat and muscle mass parameters after the administration of exogenous melatonin.;To assess sedentary behavior, assessed by the IPAQ International Physical Activity Questionnaire. It is expected to find a reduction in sitting time after 3 months of melatonin administration. | — |
Countries
Brazil
Contacts
Public ContactSusy Saraiva
Fundação de Amparo à Pesquisa do Estado de São Paulo
Outcome results
None listed