Clinical trial NCT06153225: Amino Acid Concentrations in Serum After Intake of Different Protein Sources
Official title: Amino Acid Concentrations in Serum After Intake of Plant Based Protein Sources
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postprandial Amino Acid Concentrations in Healthy Adults
Keywords: Postprandial
Healthy individuals
Amino acid
Bioavailability
Protein
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and ≤ 70 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 27.0 kg/m2
3. Written informed consent
4. Willingness and ability to comply with the protocol
5. Judged by the Investigator to be in good health

Exclusion Criteria:

1. 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
2. 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
3. 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
4. Allergy to soy, pea and/or cow's milk protein
5. Adherence to a weight loss program
6. Current eating disorder, e.g. anorexia nervosa or bulimia
7. Known pregnancy and/or lactation
8. 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)
9. 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)
10. Drug or medicine abuse in opinion of the investigator
11. Any known bleeding disorder
12. Known difficulties with placement of and/or blood drawings from a cannula
13. Active participation in any other study with investigational or marketed products concomitantly or within 4 weeks prior to screening
14. Major medical or major surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation
15. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
16. Employees of Nutricia Research and/or their family members or relatives

Primary outcomes:
measure: Amino Acid concentration in blood
timeFrame: 240 minutes after dietary protein ingestion
Secondary outcomes:
measure: Individual Amino Acid concentration in blood
timeFrame: 240 minutes after dietary protein ingestion
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: NCRU
Study officials:
References: