Nutritional and metabolic diseases
Conditions
Interventions
Participants were randomly allocated to the intervention (n = 25) and control (n = 21) groups for the first phase of the study, which lasted three months. In the second stage, also lasting three month
Dietary supplement
D26.660
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Women; age 20-50 years; body mass index less than ou equal to 25.0 and less than 40.0 kg/m²; working for at least six months on the current night shift; commiting not to change eating or physical activity habits while participating in the study.
Exclusion criteria
Exclusion criteria: Pregnant women; lactants; having children under one year old; eating disorders diagnosed by a doctor; holding a second night shift job; body mass index less than 25.0 or more than or equal to 40.0 kg/m²; regular use of medications or supplements that influence sleep, alertness and the circadian timing system (barbiturates, antidepressants, benzodiazepines, soporifics, melatonin, methylphenidate, modafinil); past history of neurological or psychiatric disorders, drug and/or alcohol abuse, sleep-wake cycle disorders, cardiovascular disease (excess treated systemic arterial hypertension), metabolic problems (except treated dyslipidemia and type 2 diabetes mellitus), inflammation and/or physician-diagnosed chronic infections; having had anemia or donated more than 400 ml of blood in the last three months prior to study participation; having had major surgery in the last six months prior to participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 - To evaluate the sleep-wake cycle using an actimeter for 10 consecutive days, including two weekends, before the beginning of the intervention, in the last 10 days of the first stage and in the last 10 days of the second stage, together with sleep and sleep diaries. completed activities to supplement information recorded by the actimeter to assess total 24-hour sleep duration, sleep efficiency, sleep latency, post-sleep activity, and type of sleep pattern.;Expected outcome 2 - We expected to find improved sleep quality, assessed by a Visual Analogue Scale (VAS) and the Pittsburgh Sleep Quality Index (PSQI), from the measurement of a scale ranging from 0-10 cm on sleep quality and perception if enough sleep was taken during the days of actimeter use and by an overall PSQI less than 5.;Expected outcome 3 - We expect to find a reduction in insomnia symptoms, which will be assessed by seven questions from the Karolinska sleep questionnaire, from which those with at least one of the seven symptoms three times a week or moreare rated as positive for insomnia.;Expected outcome 4 - It is expected to find improved physiological parameters (blood pressure and heart rate) and biochemistry (glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, triglycerides and glycated hemoglobin; the physiological parameters will be measured three times at intervals of two minutes and using only the mean value in the analysis, while blood collection will be performed in a 12-hour fasting, always after a night between shifts or off; the categorization of results will be evaluated according to the normality criteria established by European Society of Cardiology. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 5 - A reduction in body mass index (BMI), waist-hip ratio (WHR) and cervical circumference is expected; weight and height will be measured by calibrated analog scale and wall stadiometer, while circumferences will be measured by flexible and inextensible anthropometric tape; BMI will be classified according to criteria established by the World Health Organization and WHR will use the criteria established by the International Federation of 35 cm or more and will be considered as a health risk factor.;Expected outcome 6 - Adequacy of food consumption is expected; Dietary intake will be assessed by food diaries completed on a typical work day and a typical day off before the start of the intervention and at each month of participation in the study, always from 19:00 to 19:00 the following day, totaling 14 days of registration; The adequacy of calories, macro and micronutrient intake will be assessed according to the current Dietary Reference Intakes (DRI) for each participant's sex and age. | — |
Countries
Brazil
Contacts
Public ContactElaine Marqueze
Universidade de São Paulo
Outcome results
None listed