NCT03541473已完成不适用
Assessment of Nutrition on Brain Energy Metabolism in Humans Aged 50+: Measurement of Phosphate Metabolites by 31P-MRS
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年5月14日最近更新:
适应症
干预措施
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
- 1
- 主要终点
- The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products
研究概览
简要总结
The objective of this research project is to determine in elderly subjects (>50 year old) by 31P-MRS the brain concentration of phosphorous metabolites species and fluxes, before and after consumption of 2 commercially available oral nutrition products
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged between 50 and 75 years
- •Healthy, based on the medical screening visit
- •Normal BMI for age (18.5-29.9 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, to the opinion of the medical expert
- •Any ongoing medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert
- •Any ongoing medication impacting the postprandial glucose and insulin response (like beta blockers), to the opinion of the medical expert
- •Any ongoing medication impacting brain metabolism or function (neuroleptics, antidepressants, anti-epileptics), to the opinion of the medical expert
- •Ongoing chemotherapy
- •Any food supplement intake (e.g. MCT, ketone salts = Calcium, Sodium, Potassium, Magnesium) or special diet (e.g. ketogenic diet) possibly impacting basal ketone levels, to the opinion of the medical expert.
- •Claustrophobia
- •Hearing disorders (the participant placed into the MRS tunnel should be able to hear from the operators, for safety purpose)
- •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, like portacath® for instance
- •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
- •Allergy to cow milk or soy proteins
- •Currently participating or having participated in an investigational 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.
研究组 & 干预措施
Peptamen® 1.5 Vanilla
Active Comparator
干预措施: Peptamen® 1.5 Vanilla (Dietary Supplement)
Boost Plus® Vanilla
Placebo Comparator
干预措施: Boost Plus® Vanilla (Dietary Supplement)
结局指标
主要结局
The change in brain NAD+/NADH ratio (RX) after the intake of the nutrition products
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"
次要结局
未报告次要终点
研究者
研究点 (1)
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