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

April 3, 2026 updated by: University Hospital, Toulouse

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31 059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipolysis at resting and during physical activity test
Time Frame: 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)
Change after 8 weeks dietary restrictions

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Claire Thalamas, MD PhD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimated)

June 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13 149 03
  • 2013-A01543-42 (Other Identifier: RCB number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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