Use of Metabonomics and Body Imaging for Metabolic Health Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 主要终点
- Screening of metabolites in plasma in fasting condition
研究概览
简要总结
The aim of this pilot study is to develop at Nestlé Research Center a database of metabolic profiles, body composition, food habits and physical activities on a large cohort of human volunteers. Analysis of collected data will serve to measure the variability of the data and to assess the potential of combining metabonomics with imaging techniques (iDXA) to monitor the metabolic and physiologic effects of foods.
详细描述
The study will be carried out at the metabolic unit of the Nestlé Research Center (Lausanne). A large cohort of subjects will be recruited among Nestlé employees. Body composition will be determined by iDXA (Dual-energy X-ray absorptiometry) and basal metabolism will be measured by metabonomic analysis of urine and plasma samples.
Individual food habits and physical activities will be assessed by questionnaires.
The clinical protocol plans also the measurement of energy expenditure (EE) by indirect calorimetry on a subset of twenty subjects. These EE data will be used to validate iDXA outcomes for resting energy expenditure.
The volunteers can participate a second time to this study in the case they would like to control the evolution of their body composition and metabolism after a period of dietary regime or physical training. In such a case, a minimum period of two months between the visits is required.
After two days of dietary restrictions, the volunteers will come in the morning at the metabolic unit at fasting state, for urine and blood sampling. The metabolism of some foods can bias the metabonomic analyses. Therefore, the consumption of alcoholic beverages, fish meals, liquorice, grapefruit, power drinks and bars, spices, mineral supplements, soft drinks, chocolate, coffee and tea limited to 2 cups per day, are not allowed during two days preceding the visit. In addition, the intake of pain-killers or antiinflammatory drugs is forbidden during the two days before the sampling of urine and blood because their metabolism alters the metabolic profiles of blood and urine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must comply with all the following inclusion criteria:
- •Having respected dietary restrictions 2 days before the visit
- •Having obtained his/her or his/her legal representative's informed consent
排除标准
- •Subjects representing one or more of the following criteria are excluded from participation in the study:
- •Pregnancy as per precaution principal to avoid risks linked to X-ray exposure
- •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 2 days before the visit day
- •Subject who cannot be expected to comply with measures
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
结局指标
主要结局
Screening of metabolites in plasma in fasting condition
时间窗: Change of plasma metabolites after a period of 2 months post baseline
Measure of plasma metabolites by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry
Food habits (Measure of food habits based on Food Frequency Questionnaires)
时间窗: Change of food habits after a period of 2 months post baseline
Measure of food habits based on Food Frequency Questionnaires
Screening of urine metabolites in fasting condition
时间窗: Change of urine metabolites after a period of 2 months post baseline
Measure of urine metabolites by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry
Lean, fat, and bone mass (Measure of full body composition in lean, fat, and bone mass)
时间窗: change of body composition after a period of 2 months following baseline
Measure of full body composition in lean, fat, and bone mass
次要结局
未报告次要终点