Meal Timing, Genetics and Weight Loss in a Mediterranean Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,788
- 试验地点
- 2
- 主要终点
- Total weight loss
研究概览
简要总结
Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. This project aims to study in a Mediterranean population the potential influence of genetics and food timing on obesity, metabolic syndrome and weight loss.
详细描述
Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. Furthermore, it has been shown that eating late at night when plasma melatonin concentrations are elevated, impairs glucose tolerance, particularly in MTNR1B risk allele carriers.
The main objective is to identify the mechanisms underlying the association between the timing of food intake, obesity and metabolic syndrome (MetS) in order to design effective weight loss therapies. The long-term goal is to determine the potential impact of more European, i.e., earlier meal timing on obesity, MetS and weight loss.
The challenge for the society is to develop evidence-based dietary interventions incorporating meal timing and genotype to combat the epidemic of obesity and MetS.
These goals will be achieved through three specific approaches:
- Epidemiological (observational study) (Aim 1): To assess in an obese population (n=5000) who will follow a weight loss program if clock-related (CLOCK, PER2, CRY, etc.) and melatonin-related variants (MTNR1B) interact with the timing of food intake to determine weight loss effectiveness and MetS features.
- Interventional (randomized controlled trials) (Aim 2): To determine the internal mechanisms of energy balance and circadian system implicated in the differential effects of food timing (lunch) on weight loss, MetS alterations and the intestinal microbiota (n=25), and to study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance in obese women (n=100).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index: >25 kg/m2
- •Age: >18 years of age
- •Caucasian
排除标准
- •Receiving treatment with thermogenic, lipogenic, or contraceptive drugs
- •Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
- •bulimia diagnosis, prone to binge eating
- •undergoing treatment with anxiolytic or antidepressant drugs
结局指标
主要结局
Total weight loss
时间窗: weekly, during the 28 weeks of treatment
Body weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg, at the same time each day.
Long term weight loss maintenance
时间窗: once at least one year after ending the treatment
Body weight will be measured in barefoot wearing light clothes, with a digital scale to the nearest 0.1 kg.
次要结局
- Macronutrient distribution dietary questionnaire(at baseline)
- Daily rhythms of activity(from 3 months to 3 years after weight loss treatment)
- Glucose(at baseline)
- Barriers to Weight Loss checklist(at baseline)
- Food timing(at baseline)
- Food habits questionnaire(at baseline)
- Physical activity questionnaire(at baseline)
- Mediterranean Diet Score questionnaire(at baseline)
- Daily rhythms of autonomus system by ambulatory electrocardiography(from 3 months to 3 years after weight loss treatment)
- Insulin(at baseline)
- Siesta timing questionnaire(at baseline)
- Individual chronotype questionnaire(at baseline)
- Total energy intake dietary questionnaire(at baseline)
- Emotional eating questionnaire(at baseline)
- Sleep timing(at baseline)
- Glycemic Index questionnaire(at baseline)
- Glucose tolerance(from 1 year to 3 years after weight loss treatment)
- Daily rhythms of wrist temperature(from 3 months to 3 years after weight loss treatment)
研究者
PROF. MARTA GARAULET AZA
Full Professor
Universidad de Murcia