Impact of Interventions With a Diet and Exercise on the Cardio-metabolic Status in Multi-risk Population
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Measure the profiles of body composition in the different groups.
研究概览
简要总结
The diseases derived from Metabolic Syndrome caused 75% of the total deaths. It is more profitable to invest in prevention than in the treatment of most cardiovascular diseases. Several institutions consider prevention as one of the main priorities in public health.
Patients with Metabolic Syndrome, undergoing Mediterranean diet and exercise program, will have lower fat mass, greater lean mass and muscle strength; in addition to the lower expression of proinflammatory biomarkers, compared to those subjected to standard diet and exercise.
OBJECTIVE: To evaluate the changes in body composition and cardiovascular risk in the population with metabolic syndrome undergoing a Mediterranean diet program and / or controlled physical activity.
Design: Experimental, longitudinal design, controlled clinical trial, randomized. Population with Metabolic Syndrome in which the effect of Mediterranean diet and / or controlled physical activity will be compared on anthropometric parameters, body composition, cardiometabolic risk and plasma biomarkers.
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
- Single (Participant)
盲法说明
Random assignment, through software, to 4 treatment groups: one, first consume the Mediterranean and exercise plan, second group will be given only nutritional plan with Mediterranean diet, the third group only exercise plan, and the fourth control group which will give a low standard low fat.
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
- •Patients with a diagnosis of metabolic syndrome.
- •Patients diagnosed with overweight.
- •Patients diagnosed with obesity.
- •Patients with a diagnosis of systemic arterial hypertension.
- •Patients diagnosed with type 2 diabetes mellitus.
- •Patients with dyslipidemia.
排除标准
- •Recent myocardial infarction
- •Pregnancy
- •Lactation
- •In pharmacological treatment for weight loss.
- •Chronic kidney disease
- •Liver failure
- •Heart failure.
- •Chronic obstructive pulmonary disease
- •Depression
- •Malabsorption syndrome
- •Chronic diarrhea
研究组 & 干预措施
Mediterranean diet and exercise plan
Random assignment, through software, to 4 groups of treatment: consume the Mediterranean diet: according to the definition, with the distribution of macronutrients: Protein contribution 0.8-1.2 gram, Carbon Hydrates 45-50% Lipids 30% An exercise plan: The "classic" exercise program who they will carry out a 5-minute warm-up program with active mobilizations. After that, they will perform intervals of 5 min with resistance to maintain the heart rate prescribed, with active breaks of 1 - 2 min, 4 repetitions. At the end, there will be a return to calm The program of high-intensity anaerobic exercise will consist of a 5-minute warm-up , followed by 5 sets of isokinetic exercise with protocol "November 20", rest of 90 s between series. The program will be done 3 times per week for 12 weeks.
干预措施: Mediterranean diet and exercise plan (Dietary Supplement)
Mediterranean diet
Random assignment, through software, to 4 groups of treatment: consume the Mediterranean diet: according to the definition, with the following distribution of macro nutrients: Protein contribution 0.8-1.2 gram Carbon Hydrates 45-50% Lipids 30%
干预措施: Mediterranean diet and exercise plan (Dietary Supplement)
Only exercise
An exercise plan: The "classic" exercise program who they will carry out a 5-minute warm-up program with active mobilizations. After that, they will perform intervals of 5 min with resistance to maintain the heart rate prescribed, with active breaks of 1 - 2 min, 4 repetitions. At the end, there will be a return to calm The program of high-intensity anaerobic exercise will consist of a 5-minute warm-up , followed by 5 sets of isokinetic exercise with protocol "November 20", rest of 90 s between series. The program will be done 3 times per week for 12 weeks.
干预措施: Mediterranean diet and exercise plan (Dietary Supplement)
Low standard low fat diet
Random assignment, through software, to 4 groups of treatment: consume the low standard low fat diet: according to the definition, with the following distribution of macro nutrients:Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 20%
干预措施: Mediterranean diet and exercise plan (Dietary Supplement)
结局指标
主要结局
Measure the profiles of body composition in the different groups.
时间窗: 3 months
Measure the basal profiles of body composition (weight in kilograms and height in meters, body mass index in kg/m\^2, bio impedance will be done by bioimpedance multifrequency, 8 points) in the different groups
Measure the profiles of pro inflammatory biomarkers.
时间窗: 3 months
Determine the basal pro-inflammatory biomarkers (interleukins 1 beta in picograms per liter , interleukin 2 in picograms per liter , interleukins 10 in picograms per liter ) in the 4 different groups.
Compare the profiles of body composition and proinflammatory biomarkers after the follow-up between the different groups in patients with metabolic syndrome.
时间窗: 3 months
To compare the profiles of body composition and proinflammatory biomarkers after a program of physical activity and feeding plan, in the different groups of patients with metabolic syndrome after the follow-up and classify by groups, responds or not responds for analysis
次要结局
未报告次要终点
研究者
Juan Antonio Suárez Cuenca
Ph D
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado