Metabolism Associated With Abdominal Fat Mass Distribution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 29-40 kg/m2
- •Aged 25-45
排除标准
- •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
结局指标
主要结局
Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
时间窗: 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).
次要结局
- Insulin sensitivity(Measured on the day before the fat meal intake)
- Basal Energy Expenditure(Basal Energy Expenditure is measured on the day preceding the fat meal intake)