Language: BG BG
← Back to results
Active (not recruiting) Not applicable NCT06735859

Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss

No applicable phase (e.g. observational)
Conditions: Type 2 Diabetes Mellitus (T2DM) Hypertension Obesity and Type 2 Diabetes Cardiovascular Diseases

Sponsor: Federal University of São Paulo

trial.available_in: БГ
Overview
This project aims to offer a quantitative and qualitative nutritional approach, along with educational nutritional guidelines for participants with Non-Communicable Chronic Diseases. The main goals are: 1- Regularization of eating habits and windows; 2- Modulation of biochemical, anthropometric, and cardiovascular parameters; 3- Increase in knowledge about healthy eating. In this way, participants will undergo a complete nutritional assessment, comprising anthropometry, biochemistry, clinical, and dietary evaluations.
Description
The study will be conducted at the Endocrinology and Hypertension Clinic of the São José do Rio Preto Medical School between 2026 and 2027, with the objective of collecting comprehensive data for an in-depth analysis of the participants. Eligible individuals will be randomly assigned to two intervention groups. Participants in the first group will follow a daytime eating window (7:00 a.m. to 7:00 p.m.), while those in the second group will follow a nighttime eating window (12:00 p.m. to 12:00 a.m.). Nutritional consultations will be conducted individually at five assessment points: Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), and Month 18 (follow-up). Each consultation will last approximately one hour per participant, and all participants will receive appointment reminders via phone or WhatsApp.
Who can participate
Inclusion Criteria: * Age: Adults \>18 years \< 80 years; Diagnosis of obesity, diabetes, and hypertension (Obesity is diagnosed when Body Mass Index (BMI) is equal to or greater than 30 kg/m², diabetes is diagnosed when fasting plasma glucose is ≥ 126 mg/dL (7.0 mmol/L), 2-hour plasma glucose during an oral glucose tolerance test is ≥ 200 mg/dL (11.1 mmol/L), HbA1c is ≥ 6.5%, or random plasma glucose is ≥ 200 mg/dL (11.1 mmol/L) with symptoms, and hypertension is diagnosed when blood pressure is consistently ≥ 140/90 mmHg on repeated measurements.); Gender: Male and female; Availability to attend quarterly meetings over a period of 18 months; Sedentary. Exclusion Criteria: * Difficulties in responding to the requested instruments; Impediments to regular attendance in data collection; No diagnosis of Obesity, Diabetes, and Hypertension; Use of insulin therapy, Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors, and Glucagon-Like Peptide-1 (GLP-1) analogs; Chronic Kidney Disease patients; Normal weight or undernourished individuals; Physical exercise practitioners (\>150 minutes of exercise/week).
Interventions
Comparison of eating windows intervention
BEHAVIORAL
Locations 1
Brazil (1)
Federal University of São Paulo (UNIFESP)
Santos , São Paulo
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
21.01.2026
Completion date
01.10.2027
Registry ID
NCT06735859
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.