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

NCT ID: NCT06735859

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is a randomized, crossover clinical trial with a washout period and follow-up.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daytime eating window (7 am - 7 pm)

Participants will be instructed to follow the assigned eating window for a period of 6 months. In the daytime eating window, there will also be encouragement for sleep hygiene practices.

Group Type ACTIVE_COMPARATOR

Comparison of eating windows intervention

Intervention Type BEHAVIORAL

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.

Nighttime eating window (12 pm - 12 am)

Participants will be instructed to follow the assigned eating window for a period of 6 months.

Group Type ACTIVE_COMPARATOR

Comparison of eating windows intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sao Jose do Rio Preto Medical School

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Luciana Pellegrini Pisani

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luciana P Pisani, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of São Paulo (UNIFESP)

Santos, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Luciana P Pisani, PhD

Role: CONTACT

[email protected]
+5513981440230

Facility Contacts

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Luciana P Pisani, PhD

Role: primary

[email protected]
+55(17)98143-4200

Other Identifiers

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82942424.9.1001.5505

Identifier Type: -

Identifier Source: org_study_id