Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet on the Evolution of Body Fat (LIPOXmax-RUN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion ( Centre Hospitalier Felix Guyon )
ClinicalTrials.gov Identifier:
NCT01464073
First received: October 21, 2011
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Obesity
Behavioral: LIPOXmax
Behavioral: 60% VO2peak
Behavioral: Good Medical Practices
Dietary Supplement: supplementation in fruits and vegetables

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de la Réunion:

Primary Outcome Measures:
  • body fat mass reduction [ Time Frame: change from baseline in body fat mass at 5 months ] [ Designated as safety issue: No ]
    body fat mass will be measured by Dual Energy X-ray absorptiometry (M0 and M5) and by impedencemetry (M0, M3, M5).


Secondary Outcome Measures:
  • oxydative stress and inflammatory status [ Time Frame: at the inclusion (M0), and at M3 and at the end of the study at M5 ] [ Designated as safety issue: No ]
    inflammatory status : TNF alpha, IL-6, Leptin and adiponectin oxydative stress : test Folin-Ciocalteu and test DPPH

  • biological parameter [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    blood glucose

  • quality of life [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    quality of life questionaire : Short-Form 36

  • feasibility in population [ Time Frame: every two weeks ] [ Designated as safety issue: No ]

    with questionaire about:

    • the adherence (number of session of physical activity are completed)
    • secondary effects of the physical exercise program (tiredness, joint pain)

  • biological parameter [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    Hb1Ac

  • biological parameter [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    insulinemia (µU/mL)

  • biological parameter [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    total cholesterol

  • biological parameter [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    HDL-C

  • biological parameter [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    LDL-C

  • biological parameter [ Time Frame: M0, M3, M5 ] [ Designated as safety issue: No ]
    triglyceride


Enrollment: 137
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm 3 : Good Medical Practices
physical exercise at home monitored by telephone (achieving a minimum of 30 minutes per day)
Behavioral: Good Medical Practices
Arm 3: The subjects initially receive the recommendations of good medical practice for physical activity (achieving at least 30min per day of "moderate" exercise).
Other Names:
  • physical exercise
  • exercise training
Dietary Supplement: supplementation in fruits and vegetables
all groups will be supplemented in fruits and vegetables (5 per day) during all the study
Other Names:
  • diet
  • dietary supplement
Active Comparator: arm 2 : 60% VO2peak
physical exercise at the intensity of 60% of VO2 peak. 4 times a week. duration will be adjusted for arm 1 and arm 2 have the same total energy expenditure by session.
Behavioral: 60% VO2peak
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.
Other Names:
  • physical exercise
  • exercise training
Dietary Supplement: supplementation in fruits and vegetables
all groups will be supplemented in fruits and vegetables (5 per day) during all the study
Other Names:
  • diet
  • dietary supplement
Experimental: arm 1 : LIPOXmax
physical exercise at the LIPOXmax intensity during 60 minutes. 4 times a week
Behavioral: LIPOXmax
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.
Other Names:
  • FAT oxydation rate
  • FATmax
  • FATOXmax
Dietary Supplement: supplementation in fruits and vegetables
all groups will be supplemented in fruits and vegetables (5 per day) during all the study
Other Names:
  • diet
  • dietary supplement

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women
  • 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

Exclusion Criteria:

  • 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
  • cancer
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464073

Locations
France
Centre Hospitalier Universitaire
Saint Pierre, île de La Réunion, France, 97448
Sponsors and Collaborators
Centre Hospitalier Felix Guyon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de la Réunion ( Centre Hospitalier Felix Guyon )
ClinicalTrials.gov Identifier: NCT01464073     History of Changes
Other Study ID Numbers: LIPOXmax
Study First Received: October 21, 2011
Last Updated: October 25, 2012
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
NIDDM
obesity
lifestyle intervention
physical exercise
diet
LIPOXmax
FATmax
fat oxydation rate

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014