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NCT Number: NCT02161926

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, 31 059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary restrictions

Other

Dietary restrictions during 8 weeks

Other names: Dietary restrictions (20 % dietary restrictions)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. insulinosensibility

    Time frame: Change after 8 weeks dietary restrictions

    To determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions)

  5. 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

  6. 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

  7. Lipoproteins metabolism

    Time frame: Change after 8 weeks dietary restrictions

    Before dietary restrictions and after dietary restrictions

  8. biomarkers identification

    Time frame: Change after 8 weeks dietary restrictions

    New urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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)

Acronym: MONA

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 12, 2014
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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