NCT03101345已完成不适用
Assessment of Nutrition on Brain Energy Metabolism: Measurement of High Energy Phosphate Metabolites by 31-phosphorous Magnetic Resonance Spectroscopy.
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年4月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- 31P metabolites
研究概览
简要总结
The objective of this research project is to determine the impact on brain HEP metabolites and fluxes of an oral consumption of a commercially available nutrition product (Peptamen® 1.5 vanilla) in healthy volunteers.
Therefore, we intend to perform 31P-MRS before and after oral intake of the nutrition product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 18-45 years
- •Healthy, based on the medical screening visit
- •Normal BMI for age (18.5-25.0 kg/m2)
- •Able to understand and to sign a written informed consent prior to trial entry
- •Informed consent signed
排除标准
- •Known type 1 or type 2 diabetes, on anamnesis
- •Family history of type 2 diabetes (parents)
- •Any other metabolic disease possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
- •Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc
- •Any history of neurological / psychological disease (meningitis, epilepsy), to the opinion of the investigator
- •Claustrophobia
- •Hearing disorders
- •Any medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert
- •Pregnancy (on anamnesis) and/or lactation
- •Having any metallic, electronic, magnetic, or mechanical implants, devices, or objects, for safety reason linked to magnetic field exposure (MRS):
- •Aneurysm clip(s)
- •Cardiac pacemaker
- •Implanted cardioverter defibrillator (ICD)
- •Electronic implant or device
- •Magnetically-activated implant or device
- •Neurostimulation system
- •Spinal cord stimulator
- •Cochlear implant or implanted hearing aid
- •Insulin or infusion pump
- •Implanted drug infusion device
- •Any type of prosthesis or implant
- •Artificial or prosthetic limb
- •Any metallic fragment or foreign body
- •Hearing aid
- •Other implant
- •Subject injured by a metallic object or foreign body
- •History of cancer within the past year
- •Allergy or intolerance to any food or compound used
- •Currently following a strict exercise program (minimum three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport
- •Currently participating or having participated in a clinical trial during the past month
- •Subjects not willing and/or not able to comply with scheduled visits and the requirements of the research protocol. Subject having a hierarchical link with the investigator or co-investigators.
- •Subject who cannot be expected to comply with the research protocol.
结局指标
主要结局
31P metabolites
时间窗: 31P metabolites and fluxes will be measured during one hour 2 times, one before product intake (control) and the second one 45 min after product intake"
The change in concentration of brain 31P metabolites
次要结局
未报告次要终点
研究者
研究点 (2)
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