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

NCT06735859 | Active Not Recruiting

• 1 other identifier: 82942424.9.1001.5505
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

type 2 diabetes; hypertension; obesity; cardiovascular diseases; nutritional intervention; sleep; eating window

Outcome Measures

Primary Outcomes (1)

• Weight (Kg)

  Weight (kg) will be estimated using the Tanita Tetrapolar Bioimpedance Scale with Octaelectrodes BC 601®. Before the consultation, participants will be instructed to attend the meeting wearing light clothing, avoiding heavy meals, fasting from water for 1 hour, and from caffeine for 24 hours prior to the exam. For the measurements, participants will be asked to remove their shoes and empty their bladder. Subsequently, the individual will be asked to step onto the scale. Data will be collected in the morning to mitigate any type of recurring body water fluctuation throughout the day.

  5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18.

Secondary Outcomes (31)

• Brain and Muscle ARNT-Like 1 (BMAL1)

  5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18.

• Circadian Locomotor Output Cycles Kaput (CLOCK)

  5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18.

• Cryptochrome Circadian Regulator 1 (CRY1)

  5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18.

• Period Circadian Regulator 1 (PER1)

  5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18.

• Ambulatory Blood Pressure Monitoring (ABPM)

  5 assessment points - Month 0 (baseline), Month 6 (end of first intervention phase), Month 9 (end of washout), Month 15 (end of second intervention phase), FOLLOW-UP Month 18.

Study Arms (2)

Daytime eating window (7 am - 7 pm)

ACTIVE COMPARATOR

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.

Behavioral: Comparison of eating windows intervention

Nighttime eating window (12 pm - 12 am)

ACTIVE COMPARATOR

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

Behavioral: Comparison of eating windows intervention

Interventions

Comparison of eating windows intervention 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.

Daytime eating window (7 am - 7 pm); Nighttime eating window (12 pm - 12 am)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Adults \>18 years \< 80 years; Diagnosis of obesity, diabetes, and hypertension (Obesity is diagnosed when Body Mass Index (BMI) is equal to or greater than 30 kg/m², diabetes is diagnosed when fasting plasma glucose is ≥ 126 mg/dL (7.0 mmol/L), 2-hour plasma glucose during an oral glucose tolerance test is ≥ 200 mg/dL (11.1 mmol/L), HbA1c is ≥ 6.5%, or random plasma glucose is ≥ 200 mg/dL (11.1 mmol/L) with symptoms, and hypertension is diagnosed when blood pressure is consistently ≥ 140/90 mmHg on repeated measurements.); Gender: Male and female; Availability to attend quarterly meetings over a period of 18 months; Sedentary.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Sao Jose do Rio Preto Medical School: collaborator

Study Sites (1)

Federal University of São Paulo (UNIFESP)

Santos, São Paulo, 11065-200, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciana P Pisani, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Impact of Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss in Chronic Diseases

Model Details: This study is a randomized, crossover clinical trial with a washout period and follow-up.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 16, 2024
• Study Start: January 21, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will only be available 12 months after publication and will be provided upon formal request to the principal researcher, in accordance with the guidelines of non-paid international journal publishers (subscription option).
• Access Criteria: After this period, the data will be provided upon formal request to the principal researcher for up to 6 months. A link will be created with direct access to the data, or upon demand and request, the data will be provided directly to the interested researchers.

Locations

BR (1)