Metabolism Associated With Abdominal Fat Mass Distribution

Obese Clinical Trial

Official title:

Metabolism Associated With Abdominal Fat Mass Distribution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726647
• Other study ID #: 08.02.NRC
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: November 9, 2012
• Start date: September 2008
• Est. completion date: April 2012

Study information

• Verified date: November 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Obese

Locations

Country	Name	City	State
Switzerland	University Hospitals, Service of endocrinology, diabetology, and metabolism	Lausanne
Switzerland	Nestlé Clinical Development Unit / Metabolic Unit	Lausanne 26

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic plasma, urine and faeces profiles as a function of fat mass distribution	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).	Changes from baseline in metabolic profiles at one day following fat meal intake	No
Secondary	Insulin sensitivity	Insulin sensitivity is measured by oral glucose tolerance test	Measured on the day before the fat meal intake	No
Secondary	Basal Energy Expenditure	Basal Energy Expenditure is measured by indirect calorimetry	Basal Energy Expenditure is measured on the day preceding the fat meal intake	No