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

NCT01464073 | Completed DMC

• 1 other identifier: LIPOXmax
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

NIDDM; obesity; lifestyle intervention; physical exercise; diet; LIPOXmax; FATmax; fat oxydation rate

Outcome Measures

Primary Outcomes (1)

• body fat mass reduction

  body fat mass will be measured by Dual Energy X-ray absorptiometry (M0 and M5) and by impedencemetry (M0, M3, M5).

  change from baseline in body fat mass at 5 months

Secondary Outcomes (10)

• oxydative stress and inflammatory status

  at the inclusion (M0), and at M3 and at the end of the study at M5

• biological parameter

  M0, M3, M5

• quality of life

  M0, M3, M5

• feasibility in population

  every two weeks

• biological parameter

  M0, M3, M5

Study Arms (3)

arm 3 : Good Medical Practices

ACTIVE COMPARATOR

physical exercise at home monitored by telephone (achieving a minimum of 30 minutes per day)

Behavioral: Good Medical Practices; Dietary Supplement: supplementation in fruits and vegetables

arm 2 : 60% VO2peak

ACTIVE COMPARATOR

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; Dietary Supplement: supplementation in fruits and vegetables

arm 1 : LIPOXmax

EXPERIMENTAL

physical exercise at the LIPOXmax intensity during 60 minutes. 4 times a week

Behavioral: LIPOXmax; Dietary Supplement: supplementation in fruits and vegetables

Interventions

LIPOXmax BEHAVIORAL

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.

Also known as: FAT oxydation rate, FATmax, FATOXmax

arm 1 : LIPOXmax

60% VO2peak BEHAVIORAL

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.

Also known as: physical exercise, exercise training

arm 2 : 60% VO2peak

Good Medical Practices BEHAVIORAL

Arm 3: The subjects initially receive the recommendations of good medical practice for physical activity (achieving at least 30min per day of "moderate" exercise).

Also known as: physical exercise, exercise training

arm 3 : Good Medical Practices

supplementation in fruits and vegetables DIETARY_SUPPLEMENT

all groups will be supplemented in fruits and vegetables (5 per day) during all the study

Also known as: diet, dietary supplement

arm 1 : LIPOXmax; arm 2 : 60% VO2peak; arm 3 : Good Medical Practices

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women
• years old
• ≤ BMI ≤40 kg / m²
• sedentary
• considered clinically stable
• able to rehabilitation training
• having signed an informed consent
• without professional activity

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Centre Hospitalier Universitaire

Saint-Pierre, Île de La Réunion, 97448, France

Location

Related Publications (1)

• Besnier F, Lenclume V, Gerardin P, Fianu A, Martinez J, Naty N, Porcherat S, Boussaid K, Schneebeli S, Jarlet E, Hatia S, Dalleau G, Verkindt C, Brun JF, Gonthier MP, Favier F. Individualized Exercise Training at Maximal Fat Oxidation Combined with Fruit and Vegetable-Rich Diet in Overweight or Obese Women: The LIPOXmax-Reunion Randomized Controlled Trial. PLoS One. 2015 Nov 10;10(11):e0139246. doi: 10.1371/journal.pone.0139246. eCollection 2015.

  PMID: 26555595 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Motor Activity

Interventions

Exercise; Dietary Supplements; Fruit; Vegetables; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutritional Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: November 3, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

FR (1)