Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age
- Conditions
- Obesity
- Interventions
- Other: dietary restrictions
- Registration Number
- NCT02161926
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue.
The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. The MONA study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.
- Detailed Description
Primary endpoint : Study the metabolic adaptations of the subcutaneous adipose tissue after a diet in elderly obese men compared to young obese men.
Secondary endpoints : Study the metabolic adaptations of skeletal muscle, the genetic adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the modifications on the physical composition, modifications of the energy expenditure in resting state and the oxidation of the substrata, study the lipoproteins metabolism and identify new biomarkers. All those endpoints are studied comparing elderly obese subjects versus young obese subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 71
- 30 < years old < 40 OR 60 < years old < 70
- obesity : 30 < BMI < 40
- stable blood pressure (diastolic <90mmHg, systolic < 140mmHg)
- glycemia < 1,26g/L, LDL cholest <1,9-1,6g/L, Triglycerides <2,5g/L
- risk factors concerning high blood pressure, diabetes and dyslipidemia under control
- Insulin dependent diabetes, non-insulin dependent diabetes
- high blood pressure
- dyslipidemia
- history of cardiovascular diseases or bariatric surgery
- undernutrition
- HbA1C >7%
- non authorized treatments : Glucagon-like peptide-1 agonists,
- incapacity to do physical activity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description obese men from 60 to 70 years old dietary restrictions Dietary restrictions in obese men (30\<Body Mass Index\<40 kg/m2) obese men from 30 to 40 years old dietary restrictions Dietary restrictions in obese men (30\<Body Mass Index\<40 kg/m2)
- Primary Outcome Measures
Name Time Method Lipolysis at resting and during physical activity test Change after 8 weeks dietary restrictions Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)
- Secondary Outcome Measures
Name Time Method Metabolic parameters in skeletal muscle Change after 8 weeks dietary restrictions To assess metabolic parameters before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Genetic markers Change after 8 weeks dietary restrictions To assess genetic markers in adipose tissue and skeletal tissue before dietary restrictions and after dietary restrictions
insulinosensibility Change after 8 weeks dietary restrictions To determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Fibrosis and inflammatory markers in adipose tissue Change after 8 weeks dietary restrictions To assess markers in adipose tissue before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Fat and muscles rates in the whole body Change after 8 weeks dietary restrictions To determine fat and muscles rates by Dexa before dietary restrictions and after dietary restrictions
Lipoproteins metabolism Change after 8 weeks dietary restrictions Before dietary restrictions and after dietary restrictions
biomarkers identification Change after 8 weeks dietary restrictions New urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions
Energetic consumption Change after 8 weeks dietary restrictions energetic consumption at resting and during physical activity, before dietary restrictions and after dietary restrictions
Trial Locations
- Locations (1)
University Hospital Toulouse
🇫🇷Toulouse, France