Protein Digestion & AbsorptionVerLysNCT05479916
The Impact of Milk Protein Glycation on Protein Digestion and Absorption
A study testing Low glycated milk protein and High glycated milk protein in people with Protein Digestion & Absorption, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Protein intake is an essential stimulus for muscle protein anabolism. The muscle protein synthetic response to protein ingestion is mainly determined by the post-prandial plasma amino acid response. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Digestion & Absorption
- What is being tested?
- Low glycated milk protein and High glycated milk protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Mar 2023to 23 Jun 2023
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- Aged between 18-35 years
- Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
- 18.5 ≤ BMI ≤ 30 kg/m2
- No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
Who cannot join
- Smoking
- Lactose intolerant or allergies to milk proteins
- Musculoskeletal disorders
- Metabolic disorders
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
- Chronic use of gastric acid suppressing medication or anti-coagulants
Show all 9Show fewer
- Unstable weight over the last three months
- Diagnosed GI tract disorders or diseases
- Blood donation in the past 2 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
About this study
Official title: The Impact of Milk Protein Glycation on Protein Digestion and Absorption in Healthy Young Men
Rationale: Protein intake is an essential stimulus for muscle protein anabolism. The muscle protein synthetic response to protein ingestion is mainly determined by the post-prandial plasma amino acid response. Milk protein often undergoes glycation during commonly applied milk processing procedures (Maillard reaction). We have previously shown that glycated protein results in lower postprandial amino acid levels. The level of protein glycation in processed dairy products might therefore be an important modulator of the overall protein quality of a product, and its ability to stimulate protein metabolism. However, it has not yet been investigated if the glycation level of dietary protein modulates its appearance in plasma as amino acids.
Objective: To compare the appearance of dietary protein-derived amino acids in plasma after ingestion of a milk protein powder with different levels of protein glycation in healthy young men.
Read more
Study design: Double blinded, randomized cross-over study. Study population: 15 healthy young males, aged 18-35 years. Intervention (if applicable): All subjects will perform two experiments in a double-blinded, randomized order: ingest 40 g of milk protein with 5% glycation level in 600 mL water, or 40 g of milk protein with 50% glycation level in 600 mL water. After ingestion, blood samples will be taken at regular intervals during a 6 hour period.
Main study parameters/endpoints: The primary endpoint will be the appearance of milk protein-derived amino acids in plasma over the full assessment period (6 h), as determined using stable isotope tracer methodology.
Read the detailed description
Proteins are mainly required as building blocks for muscle maintenance and muscle growth. To supply these building blocks for growth and development, proteins need to be well digested, and absorbed in the circulation.
Processing of milk to produce dairy products, such as milk protein powders, may affect protein quality. Heat processes can impact native protein structure, for example by inducing protein denaturation and aggregation. In addition, reducing sugars such as lactose can react with the amino group of amino acids, known as the Maillard reaction or protein glycation. Glycation levels in milk protein powders can range from 5-50%, depending on factors such as water content and storage temperature.
Several in vitro and animal studies have shown that protein glycation decreases protein digestibility. In addition, we have recently demonstrated that protein glycation reduces post-prandial amino acid availability in humans. This reduced postprandial amino acid availability could mostly be attributed to a reduction in postprandial availability of the essential amino acid lysine. The lower post-prandial availability of amino acids following ingestion of protein with a high glycation level suggests an impaired digestion and absorption of glycated dietary protein.
Therefore, to test whether ingestion of a high glycated milk protein results in a lower appearance of dietary protein-derived amino acids, a human trial has been designed. Subjects will consume a low or high glycated milk protein drink, where after several blood samples will be taken to assess the appearance of dietary protein-derived amino acids over time by using a continuous amino acid tracer infusion. The low and high glycated protein drinks reflect the lower and upper range of protein glycation reported in dairy protein products. We hypothesize that protein glycation attenuates the appearance of dietary protein-derived amino acids in plasma.
- Conditions
- Protein Digestion & Absorption
- Being tested
- Low glycated milk protein, High glycated milk protein
- Keywords
- Protein digestion, Protein glycation, Processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycated milk proteinDietary supplement
40 grams of protein dissolved in 600 mL of water
High glycated milk proteinDietary supplement
40 grams of protein dissolved in 600 mL of water
| Study group | Role | What they receive |
|---|---|---|
| Low glycated milk protein | Experimental | 40 grams of low glycated milk protein, blocked lysine level ~5% Receives: Dietary Supplement: Low glycated milk protein |
| High glycated milk protein | Experimental | 40 grams of high glycated milk protein, blocked lysine level ~50% Receives: Dietary Supplement: High glycated milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma appearance of dietary amino acids
Appearance of milk protein-derived amino acids in plasma over the full assessment period (6 h), as determined using stable isotope tracer methodology
Measured: 0-6 hours
Secondary outcomes (6)
Whole-body protein kinetics
total rate of appearance, exogenous rate of appearance, endogenous rate of appearance, rate of disappearance
Measured: 0-6 hours
Whole body protein metabolism
Protein synthesis, breakdown, oxidation, and net balance
Measured: 0-6 hours
Peak plasma lysine concentration
Maximum plasma lysine concentration
Measured: 0-6 hours
Overall plasma amino acid responses
Plasma amino acid concentration before and after intake of the drink
Measured: 0-6 hours
Plasma glucose concentrations
Plasma glucose concentrations
Measured: 0-6 hours
Plasma insulin concentrations
Plasma insulin concentrations
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start15 Mar 2023
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
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 Protein Digestion & AbsorptionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Double blind, randomized, cross-over intervention study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479916
- Sponsor's protocol ID
- METC 22-004
- Acronym
- VerLys
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2022
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Lieshout GAA, Trommelen J, Nyakayiru J, van Kranenburg J, Senden JM, Gijsen AP, Verdijk LB, Pellikaan WF, Bragt MC, van Loon LJ. Protein glycation compromises the bioavailability of milk protein-derived lysine in vivo in healthy adult males: a double-blind, randomized cross-over trial. Am J Clin Nutr. 2025 Apr;121(4):804-815. doi: 10.1016/j.ajcnut.2025.01.025. Epub 2025 Jan 25.
PubMed 39870248
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Milk Protein Glycation on Protein Digestion and Absorption in Healthy Young Men
- ClinicalTrials.gov ID
- NCT05479916
- Acronym / sponsor ID
- VerLys / METC 22-004
- Conditions
- Protein Digestion & Absorption
- Keywords
- Protein digestion, Protein glycation, Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 29 Jul 2022 (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.
Rationale: Protein intake is an essential stimulus for muscle protein anabolism. The muscle protein synthetic response to protein ingestion is mainly determined by the post-prandial plasma amino acid response. Milk protein often undergoes glycation during commonly applied milk processing procedures (Maillard reaction). We have previously shown that glycated protein results in lower postprandial amino acid levels. The level of protein glycation in processed dairy products might therefore be an important modulator of the overall protein quality of a product, and its ability to stimulate protein metabolism. However, it has not yet been investigated if the glycation level of dietary protein modulates its appearance in plasma as amino acids.
Objective: To compare the appearance of dietary protein-derived amino acids in plasma after ingestion of a milk protein powder with different levels of protein glycation in healthy young men.
Study design: Double blinded, randomized cross-over study. Study population: 15 healthy young males, aged 18-35 years. Intervention (if applicable): All subjects will perform two experiments in a double-blinded, randomized order: ingest 40 g of milk protein with 5% glycation level in 600 mL water, or 40 g of milk protein with 50% glycation level in 600 mL water. After ingestion, blood samples will be taken at regular intervals during a 6 hour period.
Main study parameters/endpoints: The primary endpoint will be the appearance of milk protein-derived amino acids in plasma over the full assessment period (6 h), as determined using stable isotope tracer methodology.
Detailed description
Proteins are mainly required as building blocks for muscle maintenance and muscle growth. To supply these building blocks for growth and development, proteins need to be well digested, and absorbed in the circulation.
Processing of milk to produce dairy products, such as milk protein powders, may affect protein quality. Heat processes can impact native protein structure, for example by inducing protein denaturation and aggregation. In addition, reducing sugars such as lactose can react with the amino group of amino acids, known as the Maillard reaction or protein glycation. Glycation levels in milk protein powders can range from 5-50%, depending on factors such as water content and storage temperature.
Several in vitro and animal studies have shown that protein glycation decreases protein digestibility. In addition, we have recently demonstrated that protein glycation reduces post-prandial amino acid availability in humans. This reduced postprandial amino acid availability could mostly be attributed to a reduction in postprandial availability of the essential amino acid lysine. The lower post-prandial availability of amino acids following ingestion of protein with a high glycation level suggests an impaired digestion and absorption of glycated dietary protein.
Therefore, to test whether ingestion of a high glycated milk protein results in a lower appearance of dietary protein-derived amino acids, a human trial has been designed. Subjects will consume a low or high glycated milk protein drink, where after several blood samples will be taken to assess the appearance of dietary protein-derived amino acids over time by using a continuous amino acid tracer infusion. The low and high glycated protein drinks reflect the lower and upper range of protein glycation reported in dairy protein products. We hypothesize that protein glycation attenuates the appearance of dietary protein-derived amino acids in plasma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, cross-over intervention study
| Arm | Type | Receives |
|---|---|---|
| Low glycated milk protein | Experimental | Dietary Supplement: Low glycated milk protein40 grams of low glycated milk protein, blocked lysine level ~5% |
| High glycated milk protein | Experimental | Dietary Supplement: High glycated milk protein40 grams of high glycated milk protein, blocked lysine level ~50% |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males
- Aged between 18-35 years
- Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
- 18.5 ≤ BMI ≤ 30 kg/m2
- No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
Key exclusion criteria (9 listed)
- Smoking
- Lactose intolerant or allergies to milk proteins
- Musculoskeletal disorders
- Metabolic disorders
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
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 |
|---|---|---|
| Low glycated milk protein40 grams of protein dissolved in 600 mL of water | Dietary supplement | Low glycated milk protein |
| High glycated milk protein40 grams of protein dissolved in 600 mL of water | Dietary supplement | High glycated milk protein |
Primary outcome
Plasma appearance of dietary amino acids
Time frame: 0-6 hours
Appearance of milk protein-derived amino acids in plasma over the full assessment period (6 h), as determined using stable isotope tracer methodology
6 secondary outcomes
Whole-body protein kinetics
Time frame: 0-6 hours
Whole body protein metabolism
Time frame: 0-6 hours
Peak plasma lysine concentration
Time frame: 0-6 hours
Overall plasma amino acid responses
Time frame: 0-6 hours
Plasma glucose concentrations
Time frame: 0-6 hours
Plasma insulin concentrations
Time frame: 0-6 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 14 Jul 2023.
- Derived from this study: PubMed 39870248van Lieshout GAA, Trommelen J, Nyakayiru J, van Kranenburg J, Senden JM, Gijsen AP, Verdijk LB, Pellikaan WF, Bragt MC, van Loon LJ. Protein glycation compromises the bioavailability of milk protein-derived lysine in vivo in healthy adult males: a double-blind, randomized cross-over trial. Am J Clin Nutr. 2025 Apr;121(4):804-815. doi: 10.1016/j.ajcnut.2025.01.025. Epub 2025 Jan 25.
- Individual participant dataSharing planned: No
Related trials for Protein Digestion & Absorption
Recruiting
Digestion and Absorption of Postbiotic Regulatory Proteins
Protein Utilization
Not yet recruitingPhase 4
A Multicenter Clinical Study on Protein Absorption Efficiency in Patients With Pancreatic Exocrine Insufficiency in the ICU
High-risk Patients With Pancreatic Exocrine Insufficiency, Enteral Nutrition Feeding
Not yet recruiting
Digestion and Absorption Kinetics of Beef Consumed Alone or as Part of a Mixed-Meal: a Crossover Trial in Young Adults
Protein Metabolism
Recruiting
Goat vs. Cow Milk Digestive Tolerance
Milk Intolerance, Milk Hypersensitivity
Active, not recruiting
ESAN III - Energy Sensing in Depression
Obesity, Gut Microbiota Modulation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycated milk protein and High glycated milk protein in people with Protein Digestion & Absorption, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 9 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 14 Jul 2023. 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 Netherlands. 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?
Plasma appearance of dietary amino acids (time frame: 0-6 hours). 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 NCT05479916, 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 14 Jul 2023.