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Metabolism Associated With Abdominal Fat Mass Distribution

This study has been completed.
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01726647
First received: November 6, 2012
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

Objectives:

The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).

No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.


Condition
Obese

Study Type: Observational
Official Title: Metabolism Associated With Abdominal Fat Mass Distribution

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Metabolic plasma, urine and faeces profiles as a function of fat mass distribution [ Time Frame: Changes from baseline in metabolic profiles at one day following fat meal intake ] [ Designated as safety issue: No ]

    Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry.

    Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry).



Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Measured on the day before the fat meal intake ] [ Designated as safety issue: No ]
    Insulin sensitivity is measured by oral glucose tolerance test

  • Basal Energy Expenditure [ Time Frame: Basal Energy Expenditure is measured on the day preceding the fat meal intake ] [ Designated as safety issue: No ]
    Basal Energy Expenditure is measured by indirect calorimetry


Enrollment: 40
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
No product is tested
No intervention

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obese women

Criteria

Inclusion Criteria:

  • BMI 29-40 kg/m2
  • Aged 25-45

Exclusion Criteria:

  • Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome
  • Pregnancy
  • Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.
  • Any therapy (contraception apart) within the run-in period of one week before the test day.
  • Subject who cannot be expected to comply with treatments and measures.
  • Subject who is affected by any specific eating disorder
  • Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
  • Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726647

Locations
Switzerland
University Hospitals, Service of endocrinology, diabetology, and metabolism
Lausanne, Switzerland, 1011
Nestlé Clinical Development Unit / Metabolic Unit
Lausanne 26, Switzerland, 1000
Sponsors and Collaborators
Nestlé
University of Lausanne Hospitals
Investigators
Principal Investigator: Vittorio Giusti, MD, PD/MER University Hospitals of Lausanne
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01726647     History of Changes
Other Study ID Numbers: 08.02.NRC
Study First Received: November 6, 2012
Last Updated: November 9, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Nestlé:
obese women
fat mass distribution
Metabolomic profiles

ClinicalTrials.gov processed this record on May 21, 2013