Amino Acids in the Blood After Eating Yoghurt and Milk Proteins

Официальное название

Determination of the Early Postprandial Essential Amino Acid Bioavailability of Yogurt vs Milk A Randomized Controlled Clinical Trial in Healthy Volunteers - A Bioavailability Study -

Обзор

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.

Вмешательства

• Другое Full fat yogurt (fermented)
  Test
• Другое Generic full fat pasteurized milk (non-fermented)
  Control

Первичные конечные точки

• Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Essential Amino Acids (EAA) in Blood After Ingestion of Product A or Product B [Срок оценки: 2 hours]

Вторичные конечные точки (4)

• Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Essential Amino Acids in Blood After Ingestion of Product A or Product B [Срок оценки: 5 hours]
• Incremental Area Under the Curve (iAUC ₀-₁₂₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B [Срок оценки: 2 hours]
• Incremental Area Under the Curve (iAUC ₀-₃₀₀) for Total Amino Acids in Blood After Ingestion of Product A or Product B [Срок оценки: 5 hours]
• Maximum Concentration (Cmax) of Total Amino Acids and Essential Amino Acids in Blood After Ingestion of Product A or Product B [Срок оценки: 5 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 1.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Нидерланды · 1 центр

• EB Medical Research — Almere Stad

Идентификаторы

NCT: NCT07243730 · 25REX0091083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗