Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Restrictions Implications on Metabolic Changes in Obese Men : Comparison Between Two Groups of Different Ages (60-70 Years Old Versus 30-40 Years Old)

Conditions
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Obesity

Intervention / Treatment
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* Other: dietary restrictions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: obese men from 60 to 70 years old<br>Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2) | Other: dietary restrictions<br>* Dietary restrictions during 8 weeks<br>* Other names: Dietary restrictions (20 % dietary restrictions);|
| Active Comparator: obese men from 30 to 40 years old<br>Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2) | Other: dietary restrictions<br>* Dietary restrictions during 8 weeks<br>* Other names: Dietary restrictions (20 % dietary restrictions);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipolysis at resting and during physical activity test | Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions) | Change after 8 weeks dietary restrictions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic parameters in skeletal muscle | To assess metabolic parameters before dietary restrictions and after dietary restrictions (20 % dietary restrictions) | Change after 8 weeks dietary restrictions | 
| Genetic markers | To assess genetic markers in adipose tissue and skeletal tissue before dietary restrictions and after dietary restrictions | Change after 8 weeks dietary restrictions | 
| Fibrosis and inflammatory markers in adipose tissue | To assess markers in adipose tissue before dietary restrictions and after dietary restrictions (20 % dietary restrictions) | Change after 8 weeks dietary restrictions | 
| insulinosensibility | To determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions) | Change after 8 weeks dietary restrictions | 
| Fat and muscles rates in the whole body | To determine fat and muscles rates by Dexa before dietary restrictions and after dietary restrictions | Change after 8 weeks dietary restrictions | 
| Energetic consumption | energetic consumption at resting and during physical activity, before dietary restrictions and after dietary restrictions | Change after 8 weeks dietary restrictions | 
| Lipoproteins metabolism | Before dietary restrictions and after dietary restrictions | Change after 8 weeks dietary restrictions | 
| biomarkers identification | New urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions | Change after 8 weeks dietary restrictions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, dietary restrictions, metabolism, nutrition, elderly