Plasma Amino Acid Appearance and DisappearanceNCT06618729
Effects of Plant-based Meat Alternatives in Comparison to Chicken Meat on Postprandial Metabolism in Healthy Adults
A study testing Pea protein, Wheat protein and Soy protein 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 meat alternatives made from different protein ingredients (pea, wheat or soy protein) in comparison to chicken 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, Wheat protein and Soy protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 31 Oct 2024to 28 May 2025
- 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 soy, pea, wheat/gluten)
- malabsorption syndromes
- gastrointestinal diseases
Show all 23Show 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
- eating disorders (especially anorexia nervosa, bulimia nervosa)
- smoking
- participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology
Bonn, North Rhine-Westphalia, 53115
About this study
Official title: Acute Effects of Plant-based Meat Alternatives Made From Pea, Wheat or Soy Protein in Comparison to Chicken Meat on Postprandial Metabolism in Healthy Women and Men
The aim of this study is to investigate the postprandial metabolic responses to plant-based meat alternatives made from different protein ingredients (pea, wheat or soy protein) in comparison to chicken in healthy adults. Therefore, young healthy subjects consume 4 test meals with 40 g of protein from pea protein, wheat protein, soy protein or chicken in a randomized order. In a postprandial period of 6 hours, parameters of protein, glucose and lipid 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 protein source and in comparison to chicken protein.
Read the detailed description
In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 40 g of protein from plant-based meat alternatives (pea, wheat and soy protein extrudate) or chicken 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 (e.g. plasma glucose, serum insulin), lipid metabolism (serum triglycerides, total cholesterol , LDL cholesterol, HDL cholesterol, free fatty acids), serum uric acids, hunger- and satiety-associated gastrointestinal hormones (serum ghrelin, plasma GLP-1), 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, Wheat protein, Soy protein, Chicken
- Keywords
- Postprandial metabolic events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pea proteinOther
Ingestion of a meal containing 40 g of protein from pea protein extrudate
Wheat proteinOther
Ingestion of a meal containing 40 g of protein from wheat protein extrudate
Soy proteinOther
Ingestion of a meal containing 40 g of protein from soy protein extrudate
ChickenOther
Ingestion of a meal containing 40 g of protein from chicken
| Study group | Role | What they receive |
|---|---|---|
| Pea protein | Experimental | Participants randomized to receive a meal containing 40 g of protein from pea protein extrudate Receives: Other: Pea protein |
| Wheat protein | Experimental | Participants randomized to receive a meal containing 40 g of protein from wheat protein extrudate Receives: Other: Wheat protein |
| Soy protein | Experimental | Participants randomized to receive a meal containing 40 g of protein from soy protein extrudate Receives: Other: Soy protein |
| Chicken | Active comparator | Participants randomized to receive a meal containing 40 g of protein from chicken meat Receives: Other: Chicken |
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 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Secondary outcomes (22)
Amino acid profile in urine
Analysis of amino acids in urine (nmol/mL)
Measured: Postprandial period of 6 hours
Urea in blood
Analysis of urea (mg/dL) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Nitrogen in blood
Analysis of nitrogen (mg/dL) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Glucose in blood
Analysis of glucose (mmol/L) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Insulin in blood
Analysis of insulin (pmol/L) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
C-peptide in blood
Analysis C-peptide (pg/ml) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120 and 360 minutes)
Glucagon in blood
Analysis of glucagon (pg/ml) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Uric acid in blood
Analysis of uric acid (mg/dL) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Calcium in blood
Analysis of calcium (mmol/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Iron in blood
Analysis of iron (µg/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Zinc in blood
Analysis of zinc (µg/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Selenium in blood
Analysis of selenium (µg/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Copper in blood
Analysis of copper (µg/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Triglycerides in blood
Analysis of triglycerides (mmol/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Total cholesterol in blood
Analysis of total cholesterol (mmol/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
LDL cholesterol in blood
Analysis of LDL cholesterol (mmol/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
HDL cholesterol in blood
Analysis of HDL cholesterol (mmol/l) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Free fatty acids in blood
Analysis of free fatty acids (mmol/L) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Gastric emptying rate
Analysis of gastric emptying rate based on paracetamol kinetics in blood (µg/mL)
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Ghrelin in blood
Analysis of ghrelin (pg/mL) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
GLP-1 in blood
Analysis of GLP-1 (pg/ml) in blood
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180 and 360 minutes)
Hunger/satiety and acceptance of the meals
Assessment of subjective hunger/satiety and acceptance of the meals by validated visual analogue scale questionnaires (paper-pencil)
Measured: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start31 Oct 2024
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618729
- Sponsor's protocol ID
- AlProPlant-HS2
- Status last verified
- Jun 2025
- First submitted
- 20 Sep 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Plant-based Meat Alternatives Made From Pea, Wheat or Soy Protein in Comparison to Chicken Meat on Postprandial Metabolism in Healthy Women and Men
- ClinicalTrials.gov ID
- NCT06618729
- Acronym / sponsor ID
- AlProPlant-HS2
- 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
- 31 Oct 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 1 Oct 2024 (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 meat alternatives made from different protein ingredients (pea, wheat or soy protein) in comparison to chicken in healthy adults. Therefore, young healthy subjects consume 4 test meals with 40 g of protein from pea protein, wheat protein, soy protein or chicken in a randomized order. In a postprandial period of 6 hours, parameters of protein, glucose and lipid 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 protein source and in comparison to chicken protein.
Detailed description
In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 40 g of protein from plant-based meat alternatives (pea, wheat and soy protein extrudate) or chicken 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 (e.g. plasma glucose, serum insulin), lipid metabolism (serum triglycerides, total cholesterol , LDL cholesterol, HDL cholesterol, free fatty acids), serum uric acids, hunger- and satiety-associated gastrointestinal hormones (serum ghrelin, plasma GLP-1), 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 protein | Experimental | Other: Pea proteinParticipants randomized to receive a meal containing 40 g of protein from pea protein extrudate |
| Wheat protein | Experimental | Other: Wheat proteinParticipants randomized to receive a meal containing 40 g of protein from wheat protein extrudate |
| Soy protein | Experimental | Other: Soy proteinParticipants randomized to receive a meal containing 40 g of protein from soy protein extrudate |
| Chicken | Active comparator | Other: ChickenParticipants randomized to receive a meal containing 40 g of protein from chicken meat |
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 (23 listed)
- pregnancy, lactation
- hypo- or hypertension
- underweight or overweight/obesity
- food intolerances and allergies (especially soy, pea, wheat/gluten)
- 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 proteinIngestion of a meal containing 40 g of protein from pea protein extrudate | Other | Pea protein |
| Wheat proteinIngestion of a meal containing 40 g of protein from wheat protein extrudate | Other | Wheat protein |
| Soy proteinIngestion of a meal containing 40 g of protein from soy protein extrudate | Other | Soy protein |
| ChickenIngestion of a meal containing 40 g of protein from chicken | Other | Chicken |
Primary outcome
Amino acid profile in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Analysis of amino acid profile in plasma (nmol/ml)
22 secondary outcomes
Amino acid profile in urine
Time frame: Postprandial period of 6 hours
Urea in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Nitrogen in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Glucose in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Insulin in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
C-peptide in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120 and 360 minutes)
Glucagon in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Uric acid in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Calcium in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Iron in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Zinc in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Selenium in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Copper in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Triglycerides in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Total cholesterol in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
LDL cholesterol in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
HDL cholesterol in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Free fatty acids in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
Gastric emptying rate
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 30, 60, 90, 120, 180, 240 and 360 minutes)
Ghrelin in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)
GLP-1 in blood
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180 and 360 minutes)
Hunger/satiety and acceptance of the meals
Time frame: Postprandial period of 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240, 300 and 360 minutes)
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 15 Jun 2025.
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
University of Bonn, Institute of Nutritional and Food Sciences, Nutritional Physiology
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, Wheat protein and Soy protein 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 23 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 15 Jun 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 6 hours (Time points: fasting (0) and 15, 30, 45, 60, 90, 120, 180, 240 and 360 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2025.