Amino Acid Concentrations in Serum After Intake of Different Protein Sources

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postprandial Amino Acid Concentrations in Healthy Adults
• Intervention / Treatment: Dietary supplement: Protein products

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danone Nutricia Research; Phone Number: +31 30 2095 000; Email: register.clinicalresearchnutricia@danone.com

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CT
    • Recruiting
    • NCRU
    • Contact: Monique Visser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sub study 1; 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; In total 4 protein products will be tested containing a single or mixture of plant and dairy protein sources in a randomized order
Experimental: Sub study 2; 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; In total 4 protein products will be tested containing a single or mixture of plant and dairy protein sources in a randomized order

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Bioavailability; Protein; Postprandial; Healthy individuals; Amino acid
• Other Study ID Numbers: SBB22R&40716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No