RecruitingNot ApplicableNCT06735859

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

Impact of Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss in Chronic Diseases

Sponsor

Federal University of São Paulo

Enrollment

32 participants

Start Date

Jan 21, 2026

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Hypertension Type 2 Diabetes Mellitus (T2DM)Obesity and Type 2 Diabetes

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether restricting the daily eating window (time-restricted eating, a form of intermittent fasting) and addressing sleep disorders can improve blood sugar control, heart health, and weight in people who have obesity, diabetes, and high blood pressure all at once. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with obesity, type 2 diabetes, AND high blood pressure - You are sedentary (not regularly physically active) - You can attend quarterly meetings over 18 months **You may NOT be eligible if...** - You use insulin, SGLT-2 inhibitors (like empagliflozin), or GLP-1 analogs (like semaglutide) - You have chronic kidney disease - You are at a normal weight or underweight - You have any condition that makes attending regular check-ins difficult Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALComparison of eating windows intervention

Participants will be randomized into two groups to follow either a daytime or nighttime eating window, with normocaloric meal plans based on the Mediterranean diet adapted to Brazilian culture. The first intervention phase will last 6 months, followed by a 3-month washout period during which participants return to their usual eating patterns. After the washout, participants will resume the same eating window for an additional 6 months. A final follow-up assessment will be conducted 3 months post-intervention to evaluate the stability of behavioral changes.