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

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)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02161926
Acronym
MONA
Enrollment
71
Registered
2014-06-12
Start date
2014-05-01
Completion date
2017-02-01
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, dietary restrictions, metabolism, nutrition, elderly

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.

Interventions

OTHERdietary restrictions

Dietary restrictions during 8 weeks

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lipolysis at resting and during physical activity testChange after 8 weeks dietary restrictionsDetermine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)

Secondary

MeasureTime frameDescription
Metabolic parameters in skeletal muscleChange after 8 weeks dietary restrictionsTo assess metabolic parameters before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Genetic markersChange after 8 weeks dietary restrictionsTo assess genetic markers in adipose tissue and skeletal tissue before dietary restrictions and after dietary restrictions
Fibrosis and inflammatory markers in adipose tissueChange after 8 weeks dietary restrictionsTo assess markers in adipose tissue before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
insulinosensibilityChange after 8 weeks dietary restrictionsTo determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Fat and muscles rates in the whole bodyChange after 8 weeks dietary restrictionsTo determine fat and muscles rates by Dexa before dietary restrictions and after dietary restrictions
Energetic consumptionChange after 8 weeks dietary restrictionsenergetic consumption at resting and during physical activity, before dietary restrictions and after dietary restrictions
Lipoproteins metabolismChange after 8 weeks dietary restrictionsBefore dietary restrictions and after dietary restrictions
biomarkers identificationChange after 8 weeks dietary restrictionsNew urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions

Countries

France

Contacts

PRINCIPAL_INVESTIGATORClaire Thalamas, MD PhD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026