Comparison of Calorie Restriction With Early Time-restricted Eating and Calorie Restriction With Mid-day Time-restricted Eating and Daily Calorie Restriction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters. Participants will be divided into three groups: early time-restriction group (8:00 AM to 4:00 PM), mid-day restriction group (1:00 PM to 9:00 PM) and daily calorie restriction group (8:00 AM to 9:00 PM). Participants will follow dietary strategy with three planned meals and calorie restriction. Anthropometrical and biochemical parameters will be measured at baseline, after one month, two months and at after three months of intervention. Resting metabolic rate, ultrasound scan of abdomen and ultrasound scan of carotid arteries will be measured at baseline and after three months of intervention. In addition, stool samples will be also taken at baseline and after three months of intervention.
详细描述
Obesity has become one of the world's most common diseases and is a major global public health challenge. Obesity contributes to an increased risk of developing various chronic diseases, such as diabetes, metabolic syndrome, hypertension, cardiovascular and kidney diseases and many others. Reducing excess body weight and improving eating habits decreases risk of disease and mortality. A lot of dietary strategies for weight loss are known and most of them are based on daily calorie restriction. Recently, an increasingly popular dietary strategy has been "time restricted eating (TRE)". In this strategy, all calorie intake is restricted within a consistent interval of less than 12 hours (4 - 10 hours). Eating window is limited to early part of the day - early TRE or mid-day TRE. Research shows that TRE has a number of beneficial effect on individuals, including weight loss, improvement of insulin sensitivity, hypercholesterolaemia, circadian rhythm of hormone secretion and other. Which TRE (early or mid-day TRE) has better health effects is still being investigated. It is also not clear how the timing, number and composition of individual meals affect on the health indicators, mentioned previously.
Therefore, the aim of our study is to evaluate and compare the effects of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters in adults with at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, anthropometry, inflammation status, glucose levels), antioxidative status, hormones (leptin, ghrelin, cortisol, insulin, adiponectin, cholecystokinin, melatonin, BDNF, IGF-1) will be measured. In addition changes in gene expression of different proteins will be examined. Moreover, stool samples will be also taken at baseline and after three months of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 25-35 kg/m2
- •+ one of the following criteria:
- •Increased waist circumference ≥ 94 cm in men and ≥ 80 cm in women
- •Fasting plasma glucose > 5,6 mmol/L
- •Elevated fasting plasma triglycerides 1,7 mmol/l
- •Reduced high-density lipoprotein (HDL)-cholesterol < 1,0 mmol/l for men, < 1,3 mmol/l for women
- •Elevated blood pressure, systolic blood pressure > 130 mm Hg and diastolic blood pressure > 85 mm Hg
- •Without medicals for hypertension and hypercholesterolemia
- •Morning or afternoon working time
排除标准
- •Pregnant or plan to be become pregnant
- •Lactating women
- •Active smoking
- •Diagnosis of diabetes
- •Eating disorders
- •Currently enrolled in a weight-management program
- •Uncontrolled medical condition due to gastrointestinal, psychiatric, rheumatologic, oncologic, hematologic or endocrine diseases
- •History of tumor
- •History of serious cardiovascular or cerebrovascular diseases
- •Taking medicines that may affect weight and appetite
研究组 & 干预措施
Early time-restricted eating with calorie restriction
Participants will follow calorie restriction with early day time-restricted eating protocol with three planned meals from 8:00 AM to 4:00 PM.
干预措施: Effects of calorie restriction and time-restricted eating on human health (Other)
Mid-day time-restricted eating with calorie restriction
Participants will follow calorie restriction with mid-day time-restricted eating protocol with three planned meals from 1:00 PM to 9:00 PM.
干预措施: Effects of calorie restriction and time-restricted eating on human health (Other)
Daily calorie restriction
Participants will follow daily calorie restriction protocol with three planned meals from 8:00 AM to 9:00 PM.
干预措施: Effects of calorie restriction and time-restricted eating on human health (Other)
结局指标
主要结局
Change in Body Weight
时间窗: three months
Changes in body weight (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
次要结局
- Antioxidative potential(three months)
- Changes in Visceral Fat Rating(three months)
- Change in Body Fat(three months)
- Glucose levels(three months)
- LDL Cholesterol(three months)
- ultrasound scan of carotid arteries(three months)
- Resting metabolic rate(three months)
- Changes in Muscle mass(three months)
- Inflammation(three months)
- ultrasound scan of abdomen(three months)
- Blood Pressure(three months)
研究者
Zala Jenko Praznikar
Associate professor
University of Primorska