Assessing amino acid levels in blood after consuming different proteins
Amino Acid Concentrations in Serum After Intake of Plant Based Protein Sources
This study tests how different types of protein affect amino acid levels in the blood of healthy adults after they eat them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nutricia Research Industry-sponsored |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06153225 on ClinicalTrials.gov |
What this trial studies
This study evaluates how different protein sources affect amino acid concentrations in the serum of healthy adults. Participants will consume a specific protein blend during each visit, which will occur in a randomized order. Blood samples will be collected at 14 different time points following protein intake to measure amino acid levels. The study includes two sub-studies, with at least 48 hours between each visit and a follow-up call after the final visit.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 70 with a BMI between 18.5 and 27.0.
Not a fit: Patients with gastrointestinal, renal, or hepatic diseases that affect protein metabolism will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal protein sources for enhancing amino acid bioavailability in healthy individuals.
How similar studies have performed: While studies on protein bioavailability exist, this specific approach of comparing different protein sources in a controlled manner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Utrecht
- Ncru — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Danone Nutricia Research
- Email: register.clinicalresearchnutricia@danone.com
- Phone: +31 30 2095 000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.