Amino Acid Concentrations in Serum After Intake of Different Protein Sources

Study Overview
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Brief Summary
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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.

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

Conditions
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Postprandial Amino Acid Concentrations in Healthy Adults

Intervention / Treatment
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* Dietary Supplement: Protein products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sub study 1<br>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. | Dietary Supplement: Protein products<br>* In total 4 protein products will be tested containing a single or mixture of plant and dairy protein sources in a randomized order<br>|
| Experimental: Sub study 2<br>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. | Dietary Supplement: Protein products<br>* In total 4 protein products will be tested containing a single or mixture of plant and dairy protein sources in a randomized order<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amino Acid concentration in blood | 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] | 240 minutes after dietary protein ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Amino Acid concentration in blood | Postprandial serum concentrations of individual amino acids [μmol/L] | 240 minutes after dietary protein ingestion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial, Healthy individuals, Amino acid, Bioavailability, Protein