Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet on the Evolution of Body Fat
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Primary outcome: body fat mass reduction, in kilograms and in % of total weight.

      Secondary outcomes: improvement of biological parameters (markers of inflammation and
      antioxidant status, blood glucose, HbA1c, insulin, cholesterol, HDL / LDL, triglycerides);
      improvement in body composition (weight, BMI, waist circumference, hip circumference, muscle
      mass), and in lipid utilization during exercise; improvement of the quality of life;
      demonstration of the feasibility in population (adherence, compliance).

      Study design: controlled, randomized, of superiority, not blind trial in 126 people divided
      into three arms of 42 people per arm: arm 1 LIPOXmax intensity of effort, arm 2 60% of VO2max
      intensity of effort, arm 3 intensity of effort according to the Guidelines of Good Medical
      Practices.

      Intervention: the 126 subjects will undergo the following exams: weight, height, waist and
      hip circumference, blood pressure, body fat measurement by impedancemetry and biphotonic
      absorptiometry, maximal cardiopulmonary exercise and effort metabolic test (by indirect
      calorimeter to determine the LIPOXmax and the crossing points of the substrates), laboratory
      tests (blood glucose, HbA1c, insulin, cholesterol total, HDL, LDL, triglycerides, CRP,
      albumin, creatinine, urinary parameters, antioxidant status, inflammatory markers);
      questionnaires about medical history and sociodemographic data; food survey (frequency
      questionnaire, quantization by photos), questionnaires on physical activity (Baecke amended),
      quality of life (SF-36), experience of physical activity. All the participants will have an
      initial nutritional education session and will receive a free supplement of 5 fruits and
      vegetables per day during all the intervention, and random urine assays will be performed to
      monitor the consumption of fruits and vegetables. Participants will be randomized into three
      arms. Arm 1: LIPOXmax arm. Subjects will perform a physical activity 4x1 hour per week at the
      optimal intensity for fat oxidation (LIPOXmax) measured by indirect calorimeter. Arm 2:
      physical activity standard arm (60% of VO2max measured by cardio respiratory exercise test).
      Subjects will realize 4 sessions per week and duration of sessions will be adjusted so that
      arms 1 and 2 have the same total energy expenditure by session. Arm 3: control arm. The
      subjects initially receive the recommendations of good medical practice for physical activity
      (achieving at least 3h30min per week of "moderate" exercise). The intervention will last 5
      months in total. For arms 1 and 2: physical activity on ergo meter bicycle controlled by a
      sports trainer, with the goal of gradual empowerment. For arm 3: self-directed activities
      with regular telephone follow-up, holding of a book on physical activities and use of a
      pedometer during walking sessions. Indemnization: all the participants will receive a monthly
      allowance for the constraints due to their participation.

      Number of subjects: to highlight a difference in average change of 1.5 kg fat mass, with a
      standard deviation of 2.0 kg, a first species risk of 1.67% (5% / 3), a power of 80%, it is
      necessary to include 38 subjects. In such circumstances it will be possible to demonstrate a
      theoretical minimum significant difference between arms of: - 2.3% on changes at 5 month of
      average percentage of body fat (SD = 3%) and - 3.8 kg on changes at 5 months of average
      weight (SD = 5 kg). Due to missing data (dropouts, lost) rate estimated at 10%, it is planned
      to include 42 subjects per arm, or 126 in total.

      Statistical analysis: single analysis in intention to treat (arms assigned by the
      randomization). Overall first species risk = 5%. Bilateral formulation of statistical tests.
      Statistical methods used: bivariate analysis (one factor ANOVA, Pearson Chi2 test or Fisher
      test), multivariate analysis (ANCOVA, logistic regression). Taking into account the
      longitudinal data (M0-M3-M5) with generalized estimating equations (GEE). Graphic
      representation of the evolutions over the study.
    

Intervention name(s): LIPOXmax; 60% VO2peak; Good Medical Practices; supplementation in fruits and vegetables
Intervention type(s): Behavioral; Behavioral; Behavioral; Dietary Supplement
Intervention description(s): Arm 1: LIPOXmax arm. Subjects will perform a physical activity 4x1 hour per week at the optimal intensity for fat oxidation (LIPOXmax) measured by indirect calorimeter.; Arm 2: physical activity standard arm (60% of VO2max measured by cardio respiratory exercise test). Subjects will realize 4 sessions per week and duration of sessions will be adjusted so that arms 1 and 2 have the same total energy expenditure by session.; Arm 3: The subjects initially receive the recommendations of good medical practice for physical activity (achieving at least 30min per day of "moderate" exercise).; all groups will be supplemented in fruits and vegetables (5 per day) during all the study
Other intervention name(s): FAT oxydation rate; FATmax; FATOXmax; physical exercise; exercise training; physical exercise; exercise training; diet; dietary supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: NIDDM; obesity; lifestyle intervention; physical exercise; diet; LIPOXmax; FATmax; fat oxydation rate