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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014