search
Back to results

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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dietary restrictions
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Obesity, dietary restrictions, metabolism, nutrition, elderly

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

obese men from 60 to 70 years old

obese men from 30 to 40 years old

Arm Description

Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)

Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)

Outcomes

Primary Outcome Measures

Lipolysis at resting and during physical activity test
Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)

Secondary Outcome Measures

Metabolic parameters in skeletal muscle
To assess metabolic parameters before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Genetic markers
To assess genetic markers in adipose tissue and skeletal tissue before dietary restrictions and after dietary restrictions
Fibrosis and inflammatory markers in adipose tissue
To assess markers in adipose tissue before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
insulinosensibility
To determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Fat and muscles rates in the whole body
To determine fat and muscles rates by Dexa before dietary restrictions and after dietary restrictions
Energetic consumption
energetic consumption at resting and during physical activity, before dietary restrictions and after dietary restrictions
Lipoproteins metabolism
Before dietary restrictions and after dietary restrictions
biomarkers identification
New urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions

Full Information

First Posted
June 6, 2014
Last Updated
January 3, 2018
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT02161926
Brief Title
Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age
Acronym
MONA
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, dietary restrictions, metabolism, nutrition, elderly

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obese men from 60 to 70 years old
Arm Type
Experimental
Arm Description
Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)
Arm Title
obese men from 30 to 40 years old
Arm Type
Active Comparator
Arm Description
Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2)
Intervention Type
Other
Intervention Name(s)
dietary restrictions
Other Intervention Name(s)
Dietary restrictions (20 % dietary restrictions)
Intervention Description
Dietary restrictions during 8 weeks
Primary Outcome Measure Information:
Title
Lipolysis at resting and during physical activity test
Description
Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)
Time Frame
Change after 8 weeks dietary restrictions
Secondary Outcome Measure Information:
Title
Metabolic parameters in skeletal muscle
Description
To assess metabolic parameters before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Time Frame
Change after 8 weeks dietary restrictions
Title
Genetic markers
Description
To assess genetic markers in adipose tissue and skeletal tissue before dietary restrictions and after dietary restrictions
Time Frame
Change after 8 weeks dietary restrictions
Title
Fibrosis and inflammatory markers in adipose tissue
Description
To assess markers in adipose tissue before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Time Frame
Change after 8 weeks dietary restrictions
Title
insulinosensibility
Description
To determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Time Frame
Change after 8 weeks dietary restrictions
Title
Fat and muscles rates in the whole body
Description
To determine fat and muscles rates by Dexa before dietary restrictions and after dietary restrictions
Time Frame
Change after 8 weeks dietary restrictions
Title
Energetic consumption
Description
energetic consumption at resting and during physical activity, before dietary restrictions and after dietary restrictions
Time Frame
Change after 8 weeks dietary restrictions
Title
Lipoproteins metabolism
Description
Before dietary restrictions and after dietary restrictions
Time Frame
Change after 8 weeks dietary restrictions
Title
biomarkers identification
Description
New urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions
Time Frame
Change after 8 weeks dietary restrictions

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Thalamas, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31 059
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs