Plasma Amino Acid Appearance and DisappearanceNCT06155656
Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Adults
A study testing Pea protein concentrate, Pea protein isolate and Pea protein extrudate in people with Plasma Amino Acid Appearance and Disappearance and Postprandial Metabolic Events, run by University of Bonn at 1 site in Germany.
Trial summary
The aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma Amino Acid Appearance and Disappearance, Postprandial Metabolic Events
- What is being tested?
- Pea protein concentrate, Pea protein isolate and Pea protein extrudate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2024to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-smoking
- metabolically healthy
- normal weight (BMI: 18,5 - 24,9 kg/m2)
- written informed consent
Who cannot join
- pregnancy, lactation
- hypo- or hypertension
- underweight or overweight/obesity
- food intolerances and allergies (especially milk protein, pea, celery)
- malabsorption syndromes
- gastrointestinal diseases
Show all 24Show fewer
- thyroid diseases
- diabetes mellitus type 1 and type 2
- impaired kidney or liver function
- anaemia
- blood coagulation disorders
- irregular menstrual cycle
- endometriosis, severe menstrual problems
- hormonal contraception
- regular use of medications (especially habitual use of paracetamol or medications that may interact with paracetamol)
- hypersensitivity to paracetamol
- body weight below 50 kg
- alcohol abuse
- glucose-6-phosphate dehydrogenase deficiency
- Gilbert's syndrome
- vegan diet
- eating disorders (especially anorexia nervosa, bulimia nervosa)
- smoking
- participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Women and Men
The aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. Therefore, young healthy subjects consume 4 test meals with 25 g of protein from pea protein concentrate, pea protein isolate, pea protein extrudate or whey protein in a randomized order. In a postprandial period of 6 hours, parameters of protein and glucose metabolism (i.a. plasma amino acids), gastric emptying and hunger/satiety are analysed. It is assumed that the plasma amino acid profile after plant protein ingestion differs depending on processing level of the protein ingredients and in comparison to whey protein.
Read the detailed description
In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 25 g of protein from plant protein ingredients (pea protein concentrate, isolate, or extrudate) or whey protein together with 1 g paracetamol, which is used as a marker for gastric emptying.
During a postprandial period of 6 hours parameters of protein metabolism (e.g. amino acids in plasma and urine), glucose metabolism (plasma glucose, serum insulin) and gastric emptying rate (based on plasma paracetamol) are analysed. Furthermore, subjective hunger/satiety and acceptance of the meals are assed using visual analogue scales. Each intervention arm will be separated by a washout period of at least 7 days.
- Being tested
- Pea protein concentrate, Pea protein isolate, Pea protein extrudate, Whey protein
- Keywords
- Postprandial metabolic events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea protein concentrateOther
Ingestion of a soup containing 25 g of protein from pea protein concentrate
Pea protein isolateOther
Ingestion of a soup containing 25 g of protein from pea protein isolate
Pea protein extrudateOther
Ingestion of a soup containing 25 g of protein from pea protein extrudate
Whey proteinOther
Ingestion of a soup containing 25 g of protein from whey protein
| Study group | Role | What they receive |
|---|---|---|
| Pea concentrate | Experimental | Participants randomized to receive a soup containing 25 g of protein from pea protein concentrate Receives: Other: Pea protein concentrate |
| Pea isolate | Experimental | Participants randomized to receive a soup containing 25 g of protein from pea protein isolate Receives: Other: Pea protein isolate |
| Pea extrudate | Experimental | Participants randomized to receive a soup containing 25 g of protein from pea protein extrudate Receives: Other: Pea protein extrudate |
| Whey | Active comparator | Participants randomized to receive a soup containing 25 g of protein from whey protein Receives: Other: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid profile in blood
Analysis of amino acid profile in plasma (nmol/ml)
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)
Secondary outcomes (12)
Parameters of protein metabolism in blood I
Analysis of urea (mg/dL and mol/L) in blood
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Parameters of protein metabolism in blood II
Analysis of nitrogen (mg/dL) in blood
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 60, 120, 180, 240 and 300 minutes)
Parameters of glucose metabolism in blood I
Analysis of glucose (mg/dL and mmol/L) in blood
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Parameters of glucose metabolism in blood II
Analysis of insulin (nmol/L and pmol/L) in blood
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Gastric emptying rate
Analysis of gastric emptying rate based on paracetamol kinetics in blood (µg/mL)
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Hunger/satiety and acceptance of the meals
Assessment of subjective hunger/satiety and acceptance of the meals by validated visual analogue scale questionnaires (e.g., 0 = not hungry at all, 10 = very hungry)
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)
Uric acid in blood
Analysis of uric acid (mg/dL and mmol/L) in blood
Measured: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Copper in blood
Analysis of copper (µg/l) in blood
Measured: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Zinc in blood
Analysis of zinc (µg/l) in blood
Measured: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Iron in blood
Analysis of iron (µg/l) in blood
Measured: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Selenium in blood
Analysis of selenium (µg/l) in blood
Measured: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Amino acid profile in urine
Analysis of amino acids in urine (nmol/mL)
Measured: Postprandial period of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start22 Jan 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasma Amino Acid Appearance and DisappearanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. Sarah Egert, University of Bonn
- Investigators
- Sarah Egert, Prof PhD, Principal investigator, Germany University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155656
- Sponsor's protocol ID
- AlProPlant-HS1
- Status last verified
- Apr 2025
- First submitted
- 7 Nov 2023
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klug L, Diekmann C, Kopp C, Acir IH, Gola S, Opaluwa C, Stoffel-Wagner B, Coenen M, Nemeth R, Daniel H, Schweiggert-Weisz U, Egert S. Delayed Plasma Amino Acid Response following Ingestion of Extruded Pea Protein Compared with Nonextruded Pea Proteins in Healthy Adults: A Randomized Crossover Trial. J Nutr. 2026 Jul 28;156(9):101746. doi: 10.1016/j.tjnut.2026.101746. Online ahead of print.
PubMed 42520972
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Women and Men
- ClinicalTrials.gov ID
- NCT06155656
- Acronym / sponsor ID
- AlProPlant-HS1
- Keywords
- Postprandial metabolic events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. Therefore, young healthy subjects consume 4 test meals with 25 g of protein from pea protein concentrate, pea protein isolate, pea protein extrudate or whey protein in a randomized order. In a postprandial period of 6 hours, parameters of protein and glucose metabolism (i.a. plasma amino acids), gastric emptying and hunger/satiety are analysed. It is assumed that the plasma amino acid profile after plant protein ingestion differs depending on processing level of the protein ingredients and in comparison to whey protein.
Detailed description
In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 25 g of protein from plant protein ingredients (pea protein concentrate, isolate, or extrudate) or whey protein together with 1 g paracetamol, which is used as a marker for gastric emptying.
During a postprandial period of 6 hours parameters of protein metabolism (e.g. amino acids in plasma and urine), glucose metabolism (plasma glucose, serum insulin) and gastric emptying rate (based on plasma paracetamol) are analysed. Furthermore, subjective hunger/satiety and acceptance of the meals are assed using visual analogue scales. Each intervention arm will be separated by a washout period of at least 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pea concentrate | Experimental | Other: Pea protein concentrateParticipants randomized to receive a soup containing 25 g of protein from pea protein concentrate |
| Pea isolate | Experimental | Other: Pea protein isolateParticipants randomized to receive a soup containing 25 g of protein from pea protein isolate |
| Pea extrudate | Experimental | Other: Pea protein extrudateParticipants randomized to receive a soup containing 25 g of protein from pea protein extrudate |
| Whey | Active comparator | Other: Whey proteinParticipants randomized to receive a soup containing 25 g of protein from whey protein |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non-smoking
- metabolically healthy
- normal weight (BMI: 18,5 - 24,9 kg/m2)
- written informed consent
Key exclusion criteria (24 listed)
- pregnancy, lactation
- hypo- or hypertension
- underweight or overweight/obesity
- food intolerances and allergies (especially milk protein, pea, celery)
- malabsorption syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pea protein concentrateIngestion of a soup containing 25 g of protein from pea protein concentrate | Other | Pea concentrate |
| Pea protein isolateIngestion of a soup containing 25 g of protein from pea protein isolate | Other | Pea isolate |
| Pea protein extrudateIngestion of a soup containing 25 g of protein from pea protein extrudate | Other | Pea extrudate |
| Whey proteinIngestion of a soup containing 25 g of protein from whey protein | Other | Whey |
Primary outcome
Amino acid profile in blood
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)
Analysis of amino acid profile in plasma (nmol/ml)
12 secondary outcomes
Parameters of protein metabolism in blood I
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Parameters of protein metabolism in blood II
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 60, 120, 180, 240 and 300 minutes)
Parameters of glucose metabolism in blood I
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Parameters of glucose metabolism in blood II
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Gastric emptying rate
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Hunger/satiety and acceptance of the meals
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)
Uric acid in blood
Time frame: Postprandial period of 5 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 300 minutes)
Copper in blood
Time frame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Zinc in blood
Time frame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Iron in blood
Time frame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Selenium in blood
Time frame: Postprandial period of 5 hours fasting (0) and 60, 120, 180, 240 and 300 minutes)
Amino acid profile in urine
Time frame: Postprandial period of 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 42520972Klug L, Diekmann C, Kopp C, Acir IH, Gola S, Opaluwa C, Stoffel-Wagner B, Coenen M, Nemeth R, Daniel H, Schweiggert-Weisz U, Egert S. Delayed Plasma Amino Acid Response following Ingestion of Extruded Pea Protein Compared with Nonextruded Pea Proteins in Healthy Adults: A Randomized Crossover Trial. J Nutr. 2026 Jul 28;156(9):101746. doi: 10.1016/j.tjnut.2026.101746. Online ahead of print.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Egert, Prof PhD principal investigator
Germany University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pea protein concentrate, Pea protein isolate and Pea protein extrudate in people with Plasma Amino Acid Appearance and Disappearance and Postprandial Metabolic Events, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino acid profile in blood (time frame: Postprandial period of 5 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 300 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.