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Amino acid concentrations in serum after intake of plant based protein sources

Amino acid concentrations in serum after intake of plant based protein sources - Plantino I and II

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56237
Enrollment
32
Registered
2023-02-13
Start date
2023-03-28
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Biobeschikbaarheid niet van toepassing

Interventions

Test products: Sub-study Plantino I: 4 protein solutions: 2 x 100% dairy protein and 2x combination of dairy protein and plant-based protein Sub-study Plantino II study: 4 protein solutions: 1 x 100%

Sponsors

Nutricia Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 and = 18.5 and

Exclusion criteria

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 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 (for example: antibiotics, anticonvulsants, prokinetics, antacids, opioid analgesics, anticoagulants, corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or insulin). 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 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 frame
Sub-study Plantino I: 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 product A or B versus product C or D and for product A versus product B: amino acid (x) content product A [g/100g protein] / amino acid (x) content product C [g/100g protein] and amino acid (x) iAUC0-240 product A [µmol/L*min] / amino acid (x) iAUC0-240 product C [µmol/L*min] amino acid (x) content product A [g/100g protein] / amino acid (x) content product D [g/100g protein] and amino acid (x) iAUC0-240 product A [µmol/L*min] / amino acid (x) iAUC0-240 product D [µmol/L*min] amino acid (x) content product B [g/100g protein] / amino acid (x) content product C [g/100g protein] and amino acid (x) iAUC0-240 product B [µmol/L*min] / amino acid (x) iAUC0-240 product C [µmol/L*min] amino acid (x) content product B [g/100g protein] / amino acid (x) content product D [g/100g protein] and amino acid (x) iAUC0-240 product B [µmol/L*min] / amino acid (x) iAUC0-240 product D [µmol/L*min] amino acid (x) content product A [g/100g protein] / amino acid (x) content product B [g/100g protein] and amino acid (x) iAUC0-240 product A [µmol/L*min] / amino acid (x) iAUC0-240 product B [µmol/L*min] where amino acid (x) = leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, alanine, arginine, asparagine, aspartic acid, glutamic acid, glutamine, glycine, serine, tyrosine, cysteine or proline Sub-study Plantino II: 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 product E, F or G versus product D: amino acid (x) content product E [g/100g protein] / amino acid (x) content product D [g/100g protein] and amino acid (x) iAUC0-240 product E [µmol/L*min] / amino acid (x) iAUC0-240 product D [µmol/L*min] amino acid (x) content product F

Secondary

MeasureTime frame
Demographics and subject characteristics Parameters for describing demographics and subject characteristics in this study are: - Sex [male/female] - Age [years] Anthropometry - Body weight [kg] - Height [m] - Calculated BMI [kg/m2] Relevant medical history Relevant prior and concomitant medication, nutritional supplements and medical interventions - Relevant prior and concomitant medication - Prior and concomitant nutritional supplements - Medical interventions Product compliance - Time for study product intake: start time study product intake [hour:minutes] and end time study product intake [hour:minutes] - Non-compliance with product intake: less than 100% of the product Protocol compliance - Adherence to instructions and restrictions

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)