Reduction of the Metabolic Syndrome in Navarra-Spain (RESMENA-S) Through an Innovative Multidisciplinary Strategy Based on the Crononutrition and Dietary Training Concepts, in Addition to Both Dietary and Psychological Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Body fat
研究概览
简要总结
The purpose of this study is to determine whether a dietary pattern based on crononutrition and dietary training, together with dietary and psychological control, can reduce the body weight, improve the oxidative and inflammatory state in subjects with diagnosed metabolic syndrome features and can reduce the prevalence of the Metabolic syndrome in the population.
详细描述
The dietary pattern that characterizes the present nutritional intervention study is based on personalized diet, by elaborating tailoring-diets for each subject regarding his energetic needs and assuring a high adherence to the Mediterranean Diet. Moreover, the diet to be performed will be a hyperproteic diet to guarantee a satiety effect and a lower recovery of the lost weight, in accordance with the results derived from the main European study about nutrition (DIOGENES). The glycemic index/load will be also controlled in the study diet. The increase of the antioxidant capacity of the diet will be increased by the intake of fruits, walnuts and virgin olive oil among other antioxidant containing foods.
The present initiative, based on the traditional diet, aims to integrate the main results obtained from diverse observational epidemiological studies and interventional studies in the dietary pattern of the present study. At the same time, the study will apply the concept of crononutrition by selecting and distributing the foods thorough the day according the physiological needs of each individual.
In addition to the quantitative and qualitative composition of the diet, the study will take into account other important factors such as the behavior habits regarding the food, the frequency of consumption, the size of the eating portions, the distribution of the portions along the day, the feeling of fullness, the eating speed and so on. The aforementioned factors have recently been shown to be related to the gain of weight.
Other non dietary factors, such as smoking habits, sedentary life, socio-economic level, will be also controlled in the present study. Moreover, the project will integrate the dietary support together with psychological support due to the fact that the state of mind has been shown to be associated with the MS in some scientific publications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35-70 years old
- •Both sexes: Male and Female
- •Metabolic Syndrome according to the IDF(2005)criteria:
- •Waist circumference cutoffs (male ≥94 cm or female ≥80 cm) plus any two of the following four factors:
- •Fasting glucose ≥5.55 mmol/L or use of antidiabetic medication
- •Systolic BP ≥130 mm Hg, diastolic BP ≥85 mm Hg, or use of antihypertensive medication
- •Fasting triglycerides ≥1.7 mm/L; and HDL-C <1.0 mm/L in men and <1.3 mm/L in women or specific treatment for this lipid abnormality
排除标准
- •Recent follow-up of diets designed for weight loss
- •Unstable weight in the past 3 months
- •Alcoholic and drug dependence
- •Hormonal treatment
- •No stable pharmacological treatment
- •Eating-disordered behaviors
- •Severe physical or mental disability
- •Pregnancy
- •Terminal disease
- •Institutionalization
结局指标
主要结局
Body fat
时间窗: One year
Through this specific nutritional intervention program we will try to reduce the metabolic syndrome features such as waist circumference, body weight and adiposity. To evaluate the body composition, bioimpedance, DEXA and anthropometry methodology will be used at the beginning and after two months of intervention.
Lipid profile
时间窗: One year
To evaluate lipid improvements the following measurements will be taking into account: * Free fatty acids * Total cholesterol * HDL-cholesterol * LDL-cholesterol
Glucose Profile
时间窗: One year
To evaluate glucose improvements the following measurements will be taking into account: * Glucose * Insulin * HOMA
次要结局
- Fatty Liver biomarkers / Non invasive liver scoring system.(May 2016- January 2017)
- Inflammation state(One year)
- Epigenetics(April 2012-July 2014)
- Peripheral neurotransmitters(March-April 2013)
- Oxidative stress(One year)
- Psychological tests(January 2010-November 2011)