Amino Acid Concentrations in Serum After Intake of Different Protein Sources

NCT ID: NCT06153225

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2024-03-31

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.

Conditions

Postprandial Amino Acid Concentrations in Healthy Adults

Keywords

Postprandial; Healthy individuals; Amino acid; Bioavailability; Protein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Protein products

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: EXPERIMENTAL

Protein products

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NCRU

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Danone Nutricia Research

Role: CONTACT

Phone: +31 30 2095 000

Email: register.clinicalresearchnutricia@danone.com

Facility Contacts

Monique Visser

Role: primary

Other Identifiers

SBB22R&40716

Identifier Type: -

Identifier Source: org_study_id