Evaluation of the Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet Rich in Fruits and Vegetables, on the Evolution of Body Fat in Overweight or Obese Women, as Part of Type 2 Diabetes Prevention in Reunion Island.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- body fat mass reduction
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of 3 of physical exercise training programs, with a supplementation in fruits and vegetables, on body composition. 126 women will be randomized into 3 groups (42 subjects per group). The first program will be conducted at a relatively low intensity of effort, corresponding to the maximum rate of lipid oxidation (LIPOXmax)measured by indirect calorimetry. The second program will be at 60% of VO2peak and the third program will be prescribed according to the Good Practices physical Guidelines (30 minutes per day at a moderate intensity). All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 5 months in total.
详细描述
Background: in Reunion Island, in 2000 the REDIA study showed a prevalence of type 2 diabetes among 30-69 years old people above 17%, a prevalence of obesity among women of 20% and 10% for men. According to the literature upon preventive strategies and/or treatment of metabolic diseases, regular physical activity associated with a balanced diet and an intake of fruits and vegetables, can reduce body fat mass and prevent the complications related to obesity. These complications are partly related to the inflammatory and oxidative stress that accompanies obesity. A diet rich in fruits and vegetables, may improve the inflammatory and oxidative status. However there is no consensus on the intensity of regular physical activity in the practices of prevention and care. These parameters are generally not individualized. International recommendations cover a wide range of exercise intensity (between 40% and 60% of maximal oxygen uptake). The research group of Jacques Mercier (CERAMM Lapeyronie-CHU Montpellier) showed the benefit of the training conducted at a relatively low intensity of effort, corresponding to the maximum rate of lipid oxidation (LIPOXmax), and its effects on the fat mass, the insulin sensitivity and the muscle metabolism, in overweight or obese people.
Main objective: to study the effects of three programs of rehabilitation training associated with a diet supplemented with fruits and vegetables, on reducing body fat in overweight or obese people.
Secondary objectives: to study the effects on the oxidative stress and the inflammatory status, compare the efficacy of these 3 programs of physical training on body composition modifications, insulin sensitivity, lipid utilization during exercise and quality of life, describe feasibility in population (compliance, motivation).
Abstract: according to data from the literature, a balanced diet combined with moderate exercise helps to fight against biological complications related to obesity and to reduce the incidence of type 2 diabetes by promoting fat loss. But there is no consensus on the intensity of physical activity prescribed. Have been shown the benefits of training performed at an individualized intensity of effort, relatively low, corresponding to the maximum rate of lipid oxidation measured by indirect calorimeter (LIPOXmax) on fat loss, sensitivity to insulin and muscle metabolism in obese or diabetic patients. However, an individualized LIPOXmax exercise training has not yet been compared to a standardized training conventionally used in the treatment of obese subjects. Furthermore, no study has yet evaluated the impact of LIPOXmax training on inflammatory and antioxidant status among overweight and obese patients. We propose to compare among overweight or obese patients, the effects of an individualized training at an intensity corresponding to LIPOXmax, the effects of a standardized training to 60% of VO2max, and the effects of a moderate and regular physical activity prescribed according to guidelines of Good Medical Practices.
At M0 participants will have anthropometric and functional examinations and laboratory tests, and will follow nutritional education sessions. They will be then randomized into 3 arms: arm 1 LIPOXmax physical activity, arm 2 60% VO2max physical activity, arm 3 physical activity according to guidelines of Good Medical Practices. Participants of the arms 1 and 2 will practice under the control of a sports instructor; participants of the arm 3 will be regularly monitored by telephone. The procedure will last 5 months. At M3 and M5 anthropometric and biological examinations will be replicated and participants will answer to questionnaires on quality of life and experience of physical activity during and after the 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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20-40 years old
- •27 ≤ BMI ≤40 kg / m²
- •sedentary
- •considered clinically stable
- •able to rehabilitation training
- •having signed an informed consent
- •without professional activity
排除标准
- •blood glucose ≥ 1.26 g / l
- •HbA1c ≥ 6.5%
- •severe hypertension (SBP ≥ 180 mmHg and / or DBP ≥ 110 mmHg)
- •hypertension (≥140/90 mmHg) untreated or treated by beta blocker or calcium blocker
- •absolute and relative contraindication to the maximal exercise test (ACC / AHA 2002) and / or physical training
- •inability to achieve the maximum exercise test and / or the metabolic exercise test by indirect calorimeter
- •uncompensated cardiovascular and / or respiratory disease revealed by exercise test
- •pacemaker or defibrillator
- •recent cardiovascular events (heart failure, treated by positive inotropic drugs, angioplasty within the last 10 days, cardiac surgery within the last 3 months, valvular disease requiring surgical correction, evolving myopericarditis, severe ventricular arrhythmias non stabilized under treatment)
- •known and documented myopathy
- •acute and chronic inflammatory disease
- •end stage renal disease
- •digestive system operation
- •treated by corticoids, thyroid hormone, antidepressant or neuroleptics
- •pregnancy
- •mental deficiency that prevents the understanding of informed consent and protocol
- •participation to another research protocol
- •attendance in the previous month to a program of rehabilitation training or a diet
- •associated evolutionary disease causing significant impairment of general condition.
结局指标
主要结局
body fat mass reduction
时间窗: change from baseline in body fat mass at 5 months
body fat mass will be measured by Dual Energy X-ray absorptiometry (M0 and M5) and by impedencemetry (M0, M3, M5).
次要结局
- quality of life(M0, M3, M5)
- oxydative stress and inflammatory status(at the inclusion (M0), and at M3 and at the end of the study at M5)
- feasibility in population(every two weeks)
- biological parameter(M0, M3, M5)