Effectiveness of Individualized Exercise Program, Combined With a Balanced Diet on the Evolution of Body Fat - Full Text View

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:

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness Obesity

U.S. FDA Resources

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 May 19, 2013

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