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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Completed

CT.gov ID

NCT02161926

Collaborator

(none)

Enrollment

Location

Arms

33.1

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: dietary restrictions	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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)

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: obese men from 60 to 70 years old Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)	Other: dietary restrictions Dietary restrictions during 8 weeks Other Names: Dietary restrictions (20 % dietary restrictions)
Active Comparator: obese men from 30 to 40 years old Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)	Other: dietary restrictions Dietary restrictions during 8 weeks Other Names: Dietary restrictions (20 % dietary restrictions)

Arm

Intervention/Treatment

Experimental: obese men from 60 to 70 years old

Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)

Other: dietary restrictions

Dietary restrictions during 8 weeks

Other Names:

Dietary restrictions (20 % dietary restrictions)

Active Comparator: obese men from 30 to 40 years old

Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)

Other: dietary restrictions

Dietary restrictions during 8 weeks

Other Names:

Dietary restrictions (20 % dietary restrictions)

Outcome Measures

Primary Outcome Measures

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

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
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)
insulinosensibility [Change after 8 weeks dietary restrictions]
To determine insulinosensibility 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
Energetic consumption [Change after 8 weeks dietary restrictions]
energetic consumption at resting and during physical activity, 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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