Overview

This trial is active, not recruiting.

Condition obesity
Treatment dietary restrictions
Sponsor University Hospital, Toulouse
Start date May 2014
End date February 2016
Trial size 71 participants
Trial identifier NCT02161926, 13 149 03, 2013-A01543-42

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)
dietary restrictions Dietary restrictions (20 % dietary restrictions)
Dietary restrictions during 8 weeks
(Active Comparator)
Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)
dietary restrictions Dietary restrictions (20 % dietary restrictions)
Dietary restrictions during 8 weeks

Primary Outcomes

Measure
Lipolysis at resting and during physical activity test
time frame: Change after 8 weeks dietary restrictions

Secondary Outcomes

Measure
Metabolic parameters in skeletal muscle
time frame: Change after 8 weeks dietary restrictions
Genetic markers
time frame: Change after 8 weeks dietary restrictions
Fibrosis and inflammatory markers in adipose tissue
time frame: Change after 8 weeks dietary restrictions
insulinosensibility
time frame: Change after 8 weeks dietary restrictions
Fat and muscles rates in the whole body
time frame: Change after 8 weeks dietary restrictions
Energetic consumption
time frame: Change after 8 weeks dietary restrictions
Lipoproteins metabolism
time frame: Change after 8 weeks dietary restrictions
biomarkers identification
time frame: Change after 8 weeks dietary restrictions

Eligibility Criteria

Male participants from 30 years up to 70 years old.

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

Additional Information

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)
Principal investigator Claire Thalamas, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital, Toulouse.