NCT06153225招募中不适用
Amino Acid Concentrations in Serum After Intake of Plant Based Protein Sources
Nutricia Research2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Amino Acid concentration in blood
研究概览
简要总结
This study assesses the amino acid concentrations in subject serum after intake of different types of proteins. The study is divided in two consecutive sub-studies. Subjects will be asked to ingest a specific protein blend each visit in a randomized order, after which blood will be drawn on 14 different time points. At least 48 hours will be kept between each visit, and the subjects receive a follow up call within 4-14 days after visit 4.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 and ≤ 70 years
- •Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
- •Written informed consent
- •Willingness and ability to comply with the protocol
- •Judged by the Investigator to be in good health
排除标准
- •Any gastrointestinal (GI) disease or surgery that may interfere with GI function and/or protein metabolism, including but not limited to phenylketonuria, pancreatitis, short bowel syndrome, celiac disease, Crohn's disease, in the opinion of the Investigator
- •Known renal or hepatic diseases that may interfere with protein metabolism, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease, in the opinion of the Investigator
- •Use of systemic antibiotics, anticonvulsants, prokinetics, antacids, medication influencing gastric acid production, systemic anticoagulants, systemic corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants or insulin within the past 3 weeks prior to screening
- •Allergy to soy, pea and/or cow's milk protein
- •Adherence to a weight loss program
- •Current eating disorder, e.g. anorexia nervosa or bulimia
- •Known pregnancy and/or lactation
- •Current smoking or stopped smoking for < 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month prior to screening)
- •Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women (on average during the last 6 months prior to screening)
- •Drug or medicine abuse in opinion of the investigator
- •Any known bleeding disorder
- •Known difficulties with placement of and/or blood drawings from a cannula
- •Active participation in any other study with investigational or marketed products concomitantly or within 4 weeks prior to screening
- •Major medical or major surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •Employees of Nutricia Research and/or their family members or relatives
结局指标
主要结局
Amino Acid concentration in blood
时间窗: 240 minutes after dietary protein ingestion
Relative content of amino acids in dietary protein and relative amount of amino acids appearing in the blood for the 4 hour period after the ingestion of different products \[μmol\]
次要结局
- Individual Amino Acid concentration in blood(240 minutes after dietary protein ingestion)
研究者
研究点 (2)
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