Status:
UNKNOWN
Amino Acid Concentrations in Serum After Intake of Different Protein Sources
Lead Sponsor:
Nutricia Research
Conditions:
Postprandial Amino Acid Concentrations in Healthy Adults
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06153225
Start Date
April 15 2023
End Date
March 31 2024
Last Update
December 11 2023
Active Locations (1)
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1
NCRU
Utrecht, Netherlands, 3584 CT