NCT06628024已完成不适用
Determination of the Postprandial Amino Acid Uptake Kinetics of Yoghurt Vs Milk: a Randomized Controlled Clinical Trial in Health Individuals - a Bioavailability Study
Nutricia Research1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年11月19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
- 23
- 试验地点
- 1
- 主要终点
- Total amino acid concentrations after ingestion of product A vs B in 16 healthy adults
研究概览
简要总结
Subjects will visit the study site twice in a fasting state. Subjects asked to consume one of the two study products in a random order. Subjects will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Blood samples will be taken at baseline and then at various timepoints after product intake. A follow up call will take place 7 days after the final study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 and ≤ 40 years at time of ICF signature
- •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 known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in 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 medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production and/or gastrointestinal motility or function and/or protein metabolism (for example: antibiotics, anticonvulsants, prokinetics, antacids, opioid analgesics, anticoagulants, corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or insulin).
- •Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome.
- •Any ongoing cancer and/or cancer treatment (except for non metastasizing cancer e.g basal cell carcinoma).
- •Known anaemia or low haemoglobin or low iron status
- •Any known bleeding disorder.
- •Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/ intermittent fasting/ high protein diet (>1.6 g/kg body weight/day) or a weight loss program.
- •Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance.
- •Known pregnancy and/or lactation.
- •Current smoking / vaping/ use of e-cigarette or stopped smoking for <
- •1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/ e-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.
- •Use of any nutritional supplements or additional protein supplements or nutritional support within 4 weeks prior to screening.
- •Known difficulties with placement of and/or blood drawings from a cannula.
- •Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit
- •Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the investigator.
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- •Employees of Danone Research and of the investigational site and/or their family members or relatives.
结局指标
主要结局
Total amino acid concentrations after ingestion of product A vs B in 16 healthy adults
时间窗: For 4 hours after product intake
To compare the relative amount (iAUC) total amino acids (TAA) appearing in the blood for the 4-hour period after the ingestion of product A versus B.
次要结局
- Maximum concentration (Cmax) after ingestion of product A vs B in 16 healthy adults(For 4 hours after product intake)
研究者
研究点 (1)
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