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OpenTrials
Completed

NCT Number: NCT01726647

Metabolism Associated With Abdominal Fat Mass Distribution

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.

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Key information

Conditions

Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Nestlé Clinical Development Unit / Metabolic Unit, Lausanne, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Metabolic plasma, urine and faeces profiles as a function of fat mass distribution

    Time frame: 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 outcomes

  1. Insulin sensitivity

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

    Insulin sensitivity is measured by oral glucose tolerance test

  2. Basal Energy Expenditure

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

    Basal Energy Expenditure is measured by indirect calorimetry

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • University of Lausanne Hospitals

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Nov 15, 2012
Registry last updated
Nov 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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