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

Last updated: January 21, 2026
Sponsor: Federal University of São Paulo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Diabetes And Hypertension

Diabetes Prevention

Treatment

Comparison of eating windows intervention

Clinical Study ID

NCT06735859
82942424.9.1001.5505
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: Adults >18 years < 80 years; Diagnosis of obesity, diabetes, and hypertension;Gender: Male and female; Availability to attend quarterly meetings over a period of 18 months; Sedentary.

Exclusion

Exclusion Criteria:

  • Difficulties in responding to the requested instruments; Impediments to regularattendance in data collection; No diagnosis of Obesity, Diabetes, and Hypertension;Use of insulin therapy, Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors, andGlucagon-Like Peptide-1 (GLP-1) analogs; Chronic Kidney Disease patients; Normalweight or undernourished individuals; Physical exercise practitioners (>150 minutesof exercise/week).

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Comparison of eating windows intervention
Phase:
Study Start date:
January 21, 2026
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • Federal University of São Paulo (UNIFESP)

    Santos, São Paulo 11065-200
    Brazil

    Site Not Available

  • Federal University of São Paulo (UNIFESP)

    Santos 3449433, São Paulo 3448433 11065-200
    Brazil

    Active - Recruiting

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