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

NCT06735859 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-24

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Comparison 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.

Sponsors & Collaborators

  • Sao Jose do Rio Preto Medical School

    collaborator OTHER

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Luciana P Pisani, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-21
Primary Completion
2027-06-30
Completion
2027-10-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735859 on ClinicalTrials.gov