NCT07243730招募中不适用
Determination of the Early Postprandial Essential Amino Acid Bioavailability of Yogurt vs Milk A Randomized Controlled Clinical Trial in Healthy Volunteers - A Bioavailability Study -
Nutricia Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B
研究概览
简要总结
Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order. Participants will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+/-5 minutes). Two blood samples will be taken at baseline and then at 14 timepoints after product intake. A follow up call will take place 7 (-3/+7) days after the final study visit.
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
- 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 the time of (Informed Consent Form) ICF signature
- •Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- •Signed 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 surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and/or gastrointestinal (GI) function in the opinion of the investigator, including but not limited to the following: phenylketonuria, pancreatitis, short bowel syndrome, inflammatory bowel disease, celiac disease, gastroesophageal reflux disease, gastric ulcer, chronic gastritis, gastrointestinal cancer, esophageal and/or gastric surgery, and any cardiovascular disease (such as hypertension, arrhythmia, or atrial fibrillation) which is not controlled with the use of medication/therapy.
- •Known renal or hepatic diseases that may interfere with protein metabolism in the opinion of the investigator, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease.
- •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 (e.g., antibiotics, anticonvulsants, prokinetics, antacids or gastric acid inhibitors, 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-melanoma skin cancer or carcinoma in situ).
- •Known anaemia.
- •A blood donation within 56 days (8 weeks) for men; or 122 days (4 months) for women; prior to the screening.
- •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 the opinion of the investigator.
- •Current eating disorders, e.g. anorexia nervosa, bulimia nervosa, binge eating disorder.
- •Use of protein, amino acid, or creatine supplements 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 participant to comply with the protocol requirements.
- •Employees of Danone Global Research & Innovation Center and of the investigational site and/or their family members or relatives.
结局指标
主要结局
Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B
时间窗: 2 hours
次要结局
- Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B(2 hours)
- Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Essential Amino Acids in Blood After Ingestion of Product A or Product B(5 hours)
- Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B(5 hours)
- Maximum Concentration (Cmax) of Total Amino Acids and Essential Amino Acids in Blood After Ingestion of Product A or Product B(5 hours)
研究者
研究点 (1)
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