Clinical trial NCT02161926: Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
dietary restrictions
metabolism
nutrition
elderly
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 71
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lipolysis at resting and during physical activity test
timeFrame: Change after 8 weeks dietary restrictions
Secondary outcomes:
measure: Metabolic parameters in skeletal muscle
timeFrame: Change after 8 weeks dietary restrictions
measure: Genetic markers
timeFrame: Change after 8 weeks dietary restrictions
measure: Fibrosis and inflammatory markers in adipose tissue
timeFrame: Change after 8 weeks dietary restrictions
measure: insulinosensibility
timeFrame: Change after 8 weeks dietary restrictions
measure: Fat and muscles rates in the whole body
timeFrame: Change after 8 weeks dietary restrictions
measure: Energetic consumption
timeFrame: Change after 8 weeks dietary restrictions
measure: Lipoproteins metabolism
timeFrame: Change after 8 weeks dietary restrictions
measure: biomarkers identification
timeFrame: Change after 8 weeks dietary restrictions
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Claire Thalamas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: