Metabolism Associated With Abdominal Fat Mass Distribution

Completed

• Conditions: Obese

• Registration Number: NCT01726647
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-10
• Study Completion: 2012-04
• Status Verified: 2012-11
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-09
• Last Update Submitted: 2012-11-09
• Study First Posted: 2012-11-15
• Last Update Posted: 2012-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic plasma, urine and faeces profiles as a function of fat mass distribution	Changes from baseline in metabolic profiles at one day following fat meal intake	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

Name	Time	Method
Insulin sensitivity	Measured on the day before the fat meal intake	Insulin sensitivity is measured by oral glucose tolerance test
Basal Energy Expenditure	Basal Energy Expenditure is measured on the day preceding the fat meal intake	Basal Energy Expenditure is measured by indirect calorimetry

Trial Locations

Locations (2)

Nestlé Clinical Development Unit / Metabolic Unit; 🇨🇭 Lausanne 26, Switzerland

University Hospitals, Service of endocrinology, diabetology, and metabolism; 🇨🇭 Lausanne, Switzerland