Obese Clinical Trial
Official title:
Metabolism Associated With Abdominal Fat Mass Distribution
Verified date | November 2012 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Observational |
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.
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 |
N/A
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospitals, Service of endocrinology, diabetology, and metabolism | Lausanne | |
Switzerland | Nestlé Clinical Development Unit / Metabolic Unit | Lausanne 26 |
Lead Sponsor | Collaborator |
---|---|
Nestlé | University of Lausanne Hospitals |
Switzerland,
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 |
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