Impact of Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss in Chronic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Weight (Kg)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Comparison of eating windows intervention (Behavioral)
Nighttime eating window (12 pm - 12 am)
Participants will be instructed to follow the assigned eating window for a period of 6 months.
干预措施: Comparison of eating windows intervention (Behavioral)
结局指标
主要结局
Weight (Kg)
时间窗: 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.
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.
次要结局
- Polysomnography (PSG)(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.])
- 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.)
- Medications(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.)
- Body fat percentage (%)(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.)
- Physical exercise(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.)
- Hip Index (HI)(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.)
- Neck circumference (cm)(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.)
- Hip circumference (cm)(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.)
- HDL cholesterol (mg/dL)(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.)
- Triglycerides (TG) (mg/dL)(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.)
- Plasma glucose (mg/dL)(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.)
- Lean mass (kg)(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.)
- Sociodemographic assessment:(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.)
- Dietary assessment (habitual food recall)(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.)
- Skipping breakfast(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.)
- Pittsburgh Sleep Quality Index (PSQI)(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.)
- Body Shape Index (ABSI)(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.)
- Blood pressure (BP) (mmHg)(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.)
- Waist/hip ratio(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.)
- Height (meters)(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.)
- Waist circumference (cm)(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.)
- BMI (Body Mass Index - Kg/m²)(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.)
- LDL cholesterol (mg/dL)(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.)
- Total cholesterol (TC) (mg/dL)(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.)
- HbA1c (%)(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.)
- Insulin (µU/mL)(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.)
- Creatinine Clearance (24-hour urine, mL/min)(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.)
研究者
Luciana Pellegrini Pisani
Impact of Eating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss in Chronic Diseases
Federal University of São Paulo