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Amino Acid Concentrations in Serum After Intake of Different Protein Sources

Amino Acid Concentrations in Serum After Intake of Plant Based Protein Sources

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06153225
Enrollment
32
Registered
2023-12-01
Start date
2023-04-15
Completion date
2024-03-31
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial Amino Acid Concentrations in Healthy Adults

Keywords

Postprandial, Healthy individuals, Amino acid, Bioavailability, Protein

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.

Interventions

DIETARY_SUPPLEMENTProtein products

In total 4 protein products will be tested containing a single or mixture of plant and dairy protein sources in a randomized order

Sponsors

Nutricia Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Amino Acid concentration in blood240 minutes after dietary protein ingestionRelative 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

MeasureTime frameDescription
Individual Amino Acid concentration in blood240 minutes after dietary protein ingestionPostprandial serum concentrations of individual amino acids \[μmol/L\]

Countries

Netherlands

Contacts

Primary ContactDanone Nutricia Research
register.clinicalresearchnutricia@danone.com+31 30 2095 000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026