Metabolism Associated With Abdominal Fat Mass Distribution

Société des Produits Nestlé (SPN)40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obese

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Nestlé Clinical Development Unit / Metabolic Unit

Lausanne, Switzerland

University Hospitals, Service of endocrinology, diabetology, and metabolism

Lausanne, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: Changes from baseline in metabolic profiles at one day following fat meal intake

Secondary Outcomes

Insulin sensitivity

Insulin sensitivity is measured by oral glucose tolerance test

Time frame: Measured on the day before the fat meal intake

Basal Energy Expenditure

Basal Energy Expenditure is measured by indirect calorimetry

Time frame: Basal Energy Expenditure is measured on the day preceding the fat meal intake

Data from ClinicalTrials.gov

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