Amino Acid Concentrations in Serum After Intake of Different Protein Sources

Not Applicable

Recruiting

• Conditions: Postprandial Amino Acid Concentrations in Healthy Adults
• Interventions: Dietary Supplement: Protein products

• Registration Number: NCT06153225
• Lead Sponsor: Nutricia Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-07
• Study Start: 2023-04-15
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-22
• Study First Posted: 2023-12-01
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sub study 1	Protein products	All subjects will receive 4 study products (300ml each) on 4 different visits in a randomized order. In total in both arms combined, 7 products will be tested.
Sub study 2	Protein products	All subjects will receive 4 study products (300ml each) on 4 different visits a randomized order. In total in both arms combined, 7 products will be tested.

Primary Outcome Measures

Name	Time	Method
Amino Acid concentration in blood	240 minutes after dietary protein ingestion	Relative content of amino acids in dietary protein and relative amount of amino acids appearing in the blood for the 4 hour period after the ingestion of different products \[μmol\]

Secondary Outcome Measures

Name	Time	Method
Individual Amino Acid concentration in blood	240 minutes after dietary protein ingestion	Postprandial serum concentrations of individual amino acids \[μmol/L\]

Trial Locations

Locations (1)

NCRU; 🇳🇱 Utrecht, Netherlands