NCT02161926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

June 6, 2014

Last Update Submit

April 3, 2026

Conditions

Obesity

Keywords

Obesitydietary restrictionsmetabolismnutritionelderly

Outcome Measures

Primary Outcomes (1)

  • 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)

    Change after 8 weeks dietary restrictions

Secondary Outcomes (8)

  • Metabolic parameters in skeletal muscle

    Change after 8 weeks dietary restrictions

  • Genetic markers

    Change after 8 weeks dietary restrictions

  • Fibrosis and inflammatory markers in adipose tissue

    Change after 8 weeks dietary restrictions

  • insulinosensibility

    Change after 8 weeks dietary restrictions

  • Fat and muscles rates in the whole body

    Change after 8 weeks dietary restrictions

  • +3 more secondary outcomes

Study Arms (2)

obese men from 60 to 70 years old

EXPERIMENTAL

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

Other: dietary restrictions

obese men from 30 to 40 years old

ACTIVE COMPARATOR

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

Other: dietary restrictions

Interventions

dietary restrictionsOTHER

Dietary restrictions during 8 weeks

Also known as: Dietary restrictions (20 % dietary restrictions)
obese men from 30 to 40 years oldobese men from 60 to 70 years old

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31 059, France

Location

Related Publications (2)

  • Vion J, Sramkova V, Montastier E, Marques MA, Caspar-Bauguil S, Duparc T, Martinez LO, Bourlier V, Harant I, Larrouy D, Moussaoui N, Bonnel S, Vindis C, Dray C, Valet P, Saulnier-Blache JS, Schanstra JP, Thalamas C, Viguerie N, Moro C, Langin D. Metabolic and cardiovascular adaptations to an 8-wk lifestyle weight loss intervention in younger and older obese men. Am J Physiol Endocrinol Metab. 2021 Sep 1;321(3):E325-E337. doi: 10.1152/ajpendo.00109.2021. Epub 2021 Jul 12.

    PMID: 34250814RESULT

  • Laurens C, Parmar A, Murphy E, Carper D, Lair B, Maes P, Vion J, Boulet N, Fontaine C, Marques M, Larrouy D, Harant I, Thalamas C, Montastier E, Caspar-Bauguil S, Bourlier V, Tavernier G, Grolleau JL, Bouloumie A, Langin D, Viguerie N, Bertile F, Blanc S, de Glisezinski I, O'Gorman D, Moro C. Growth and differentiation factor 15 is secreted by skeletal muscle during exercise and promotes lipolysis in humans. JCI Insight. 2020 Mar 26;5(6):e131870. doi: 10.1172/jci.insight.131870.

    PMID: 32106110RESULT

MeSH Terms

Conditions

Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Claire Thalamas, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 12, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2017

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

FR(1)