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

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ClinicalTrials.gov Identifier: NCT02161926
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.


Condition or disease Intervention/treatment Phase
Obesity Other: dietary restrictions Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : May 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2017
Arms and Interventions
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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 Name: 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 Name: Dietary restrictions (20 % dietary restrictions)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161926


Locations
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France
University Hospital Toulouse
Toulouse, France, 31 059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Claire Thalamas, MD PhD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02161926    
Other Study ID Numbers: 13 149 03
2013-A01543-42 ( Other Identifier: RCB number )
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Obesity
dietary restrictions
metabolism
nutrition
elderly
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight