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

Last updated: February 23, 2025
Sponsor: Federal University of São Paulo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diabetes Mellitus, Type 2

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: 48
Treatment Group(s): 1
Primary Treatment: Comparison of eating windows intervention
Phase:
Study Start date:
February 17, 2025
Estimated Completion Date:
November 19, 2027

Study Description

The study will be conducted at the Endocrinology and Hypertension Clinic of the São José do Rio Preto Medical School from 2025 to 2027, aiming to collect data for a thorough analysis of the participants. The study participants will be randomly assigned to 2 groups (intervention 1 and intervention 2). Participants in the first group will follow a daytime eating window (7 am - 7 pm). Participants in the second group will follow a nighttime eating window (12 pm - 12 am). Nutritional consultations will be individual and will occur once every 3 months until the conclusion of the study, according to the clinic's scheduling availability. The average duration of each session will be approximately 1 hour per participant. All participants will be reminded of their appointments via phone/WhatsApp.

Connect with a study center

  • Federal University of São Paulo (UNIFESP)

    Santos, São Paulo 11065-200
    Brazil

    Active - Recruiting

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