Metabolism Associated With Abdominal Fat Mass Distribution

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01726647

Enrollment

Registered

2012-11-15

Start date

2008-09-30

Completion date

2012-04-30

Last updated

2012-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese

Keywords

obese women, fat mass distribution, Metabolomic profiles

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.

Interventions

None listed

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Switzerland

Outcome results