Muscle Protein SynthesisStrongplantNCT05711095
The Anabolic Properties of Fortified Plant-based Protein in Older People
A study testing Fortified plant-based protein blend, Plant-based protein blend and Whey protein in people with Muscle Protein Synthesis and Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. Conventional animal-based protein sources such as meat, poultry, fish, eggs, and dairy are considered high-quality sources of dietary protein. Read more about this study
- Who is it for?
- Ages 60 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthesis, Sarcopenia
- What is being tested?
- Fortified plant-based protein blend, Plant-based protein blend and Whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Sep 2023to 13 Sep 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 60 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex
- Aged between 60 and 85 y inclusive
- BMI between 18.5 and 35 kg/m2
Who cannot join
- Vegetarian and vegan diet
- Intolerant to milk products
- Soy allergy
- Pea allergy
- Participating in a structured (progressive) exercise program
- Smoking regularly (i.e. >5 cigarettes/week)
Show all 16Show fewer
- Diagnosed GI tract disorders or diseases
- Diagnosed musculoskeletal disorders
- Diagnosed metabolic disorders (e.g. diabetes)
- Diagnosed with phenylketonuria (PKU)
- Uncontrolled hypertension (blood pressure above 160/100 mmHg)
- Donated blood 3 months prior to test day
- Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories).
- Chronic use of gastric acid suppressing medication
- Chronic use of anti-coagulants
- Recent (<1 year) participation in amino acid tracer studies (L-[ring-13C6]-phenylalanine and L-[3,5-2H2]-tyrosine)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center+
Maastricht, Limburg, 6229ER
About this study
Official title: The Effect of Ingesting a Novel Fortified Plant-based Protein Mix on Acute Muscle Protein Synthesis in Older People
Rationale: Consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. Conventional animal-based protein sources such as meat, poultry, fish, eggs, and dairy are considered high-quality sources of dietary protein. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands will be challenging. Consequently, there is a great interest in more sustainable alternatives for these high-quality protein sources. Plant-derived proteins can be produced on a more sustainable scale, but are generally considered lower quality protein sources compared to animal-based sources because of incomplete essential amino acid profiles, resulting in lower anabolic properties for skeletal muscle building. Blending different plant-derived proteins can be a solution, but will never match the profile of other high-quality animal-derived proteins, likely necessitating the fortification of such plant-based protein blends with essential amino acids such as leucine.
Objective: To assess post-prandial muscle protein synthesis rates in older males in response to ingesting a blend of plant protein fortified with free leucine compared to (gold standard) whey protein and compared to the plant protein blend without additional leucine.
Read more
Study design: randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial.
Study population: 45 healthy (BMI 18.5-35 kg/m2) older males (age: 60-85 y inclusive).
Intervention: Subjects will consume a beverage containing 20g whey protein isolate, 20g of a plant protein blend or the same plant protein blend fortified with 2g leucine. Continuous intravenous stable isotope amino acid tracer infusions will be applied, with plasma and muscle samples collected at different time points throughout the experimental test day.
Main study parameters/endpoints: The primary outcome will be postprandial (0-4h) muscle protein synthesis rates following beverage ingestion.
Read the detailed description
Aging is accompanied by a loss of skeletal muscle mass and muscle strength. Besides physical activity, the consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. As older individuals express anabolic resistance to protein intake, it is thought that older people can improve the anabolic response by ingesting higher protein doses. However, ingesting large protein doses is not always feasible. Alternatively, protein quality represents an important factor affecting the anabolic response to food intake.
Conventional animal-based protein sources such as meat and dairy are generally considered high-quality sources of dietary protein because they meet all of the indispensable amino acid requirements for humans and are highly digestible. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands represents a massive challenge. Presently, there is a great interest in plant-based proteins as a more sustainable alternative for animal-based proteins. Current data shows that plant-based proteins are generally of a lesser quality when compared to animal-based protein, like whey protein, as evidenced by a lower indispensable amino acid content and deficiencies in one or more specific amino acids (i.e. lysine, leucine and/or methionine). This also translates to a compromised bioavailability and lesser anabolic properties. Studies show that ingestion of a single bolus of a plant protein increases muscle protein synthesis rates to a lesser extent when compared to animal-based proteins.
Combining different types of plant-derived proteins to overcome the amino acid deficiencies has been proposed as a strategy to increase the anabolic properties of plant-derived proteins. However, it is not possible to match the amino acid composition to that of the gold standard, whey protein. Another strategy to improve the anabolic properties of plant-derived proteins is fortification with free essential amino acids. Previously, ingestion of 40g of protein as a lysine fortified meat substitute was shown to increase muscle protein synthesis rates to a similar level as the ingestion of chicken. However, it is unclear whether this similarity was caused by the lysine enrichment or by the ingestion of a really high dose of protein that could have maximized muscle protein synthesis rates. Therefore, the principle of fortification is still to be investigated with the ingestion of a much lower (submaximal, but more realistic) dose of 20g protein.
Therefore, the aim of the current study is to assess postprandial muscle protein synthesis rates in older males in response to ingestion of a blend of plant protein (20g) fortified with free leucine, as compared to the blend of plant protein without additional leucine, and compared to whey protein as the gold standard.
Two primary hypotheses will be tested:
- it is hypothesized that postprandial muscle protein synthesis rates will be higher following ingestion of the fortified plant protein blend when compared to the normal plant protein blend
- it is hypothesized that postprandial muscle protein synthesis rates will be at least as high following ingestion of the fortified plant protein blend when compared to whey protein.
- Conditions
- Muscle Protein Synthesis, Sarcopenia
- Being tested
- Fortified plant-based protein blend, Plant-based protein blend, Whey protein
- Keywords
- Muscle metabolism, Dietary protein, Plant protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified plant-based protein blendDietary supplement
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Plant-based protein blendDietary supplement
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
Whey proteinDietary supplement
20 grams of protein dissolved in 500 mL water from a non-transparent shaker
| Study group | Role | What they receive |
|---|---|---|
| Fortified plant protein blend | Experimental | 20g of plant-based protein blend fortified with 2 g leucine Receives: Dietary Supplement: Fortified plant-based protein blend |
| Normal plant protein blend | Experimental | 20g of plant-based protein blend Receives: Dietary Supplement: Plant-based protein blend |
| Whey protein | Active comparator | 20g of whey protein Receives: Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial muscle protein fractional synthesic rate
Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.
Measured: 0-4 hours
Secondary outcomes (4)
Postabsorptive ('basal') muscle protein fractional synthesis rate
Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.
Measured: -3 - 0 hours
Plasma amino acids concentrations
Post-prandial plasma amino acid availability
Measured: 0-4 hours
Plasma glucose concentrations
Post-prandial plasma glucose availability
Measured: 0-4 hours
Plasma insulin concentrations
Post-prandial plasma insulin availability
Measured: 0-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start21 Sep 2023
- Primary completion13 Sep 2024
- Study completion13 Sep 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 Muscle Protein SynthesisStudies 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
- Parallel groups
- Model description
- Randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Nutricia
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711095
- Sponsor's protocol ID
- METC 22-049
- Acronym
- Strongplant
- Status last verified
- May 2025
- First submitted
- 20 Jan 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuin LME, Hermans WJH, Boot N, Fuchs CJ, Senden JM, Zorenc AH, Overman A, van Kranenburg JMX, Goessens JPB, Verdijk LB, van Dijk M, Furber M, van Helvoort A, van Loon LJC. Ingestion of 20 g of a plant-derived protein blend with and without added leucine or whey protein does not increase muscle protein synthesis rates in older males. J Nutr. 2026 Aug 17:101789. doi: 10.1016/j.tjnut.2026.101789. Online ahead of print.
PubMed 42607838
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ingesting a Novel Fortified Plant-based Protein Mix on Acute Muscle Protein Synthesis in Older People
- ClinicalTrials.gov ID
- NCT05711095
- Acronym / sponsor ID
- Strongplant / METC 22-049
- Conditions
- Muscle Protein Synthesis, Sarcopenia
- Keywords
- Muscle metabolism, Dietary protein, Plant protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Danone Nutricia
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 2 Feb 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.
Rationale: Consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. Conventional animal-based protein sources such as meat, poultry, fish, eggs, and dairy are considered high-quality sources of dietary protein. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands will be challenging. Consequently, there is a great interest in more sustainable alternatives for these high-quality protein sources. Plant-derived proteins can be produced on a more sustainable scale, but are generally considered lower quality protein sources compared to animal-based sources because of incomplete essential amino acid profiles, resulting in lower anabolic properties for skeletal muscle building. Blending different plant-derived proteins can be a solution, but will never match the profile of other high-quality animal-derived proteins, likely necessitating the fortification of such plant-based protein blends with essential amino acids such as leucine.
Objective: To assess post-prandial muscle protein synthesis rates in older males in response to ingesting a blend of plant protein fortified with free leucine compared to (gold standard) whey protein and compared to the plant protein blend without additional leucine.
Study design: randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial.
Study population: 45 healthy (BMI 18.5-35 kg/m2) older males (age: 60-85 y inclusive).
Intervention: Subjects will consume a beverage containing 20g whey protein isolate, 20g of a plant protein blend or the same plant protein blend fortified with 2g leucine. Continuous intravenous stable isotope amino acid tracer infusions will be applied, with plasma and muscle samples collected at different time points throughout the experimental test day.
Main study parameters/endpoints: The primary outcome will be postprandial (0-4h) muscle protein synthesis rates following beverage ingestion.
Detailed description
Aging is accompanied by a loss of skeletal muscle mass and muscle strength. Besides physical activity, the consumption of sufficient dietary protein is fundamental to skeletal muscle mass maintenance and overall health. As older individuals express anabolic resistance to protein intake, it is thought that older people can improve the anabolic response by ingesting higher protein doses. However, ingesting large protein doses is not always feasible. Alternatively, protein quality represents an important factor affecting the anabolic response to food intake.
Conventional animal-based protein sources such as meat and dairy are generally considered high-quality sources of dietary protein because they meet all of the indispensable amino acid requirements for humans and are highly digestible. However, the production of sufficient amounts of these conventional animal-based proteins to meet future global food demands represents a massive challenge. Presently, there is a great interest in plant-based proteins as a more sustainable alternative for animal-based proteins. Current data shows that plant-based proteins are generally of a lesser quality when compared to animal-based protein, like whey protein, as evidenced by a lower indispensable amino acid content and deficiencies in one or more specific amino acids (i.e. lysine, leucine and/or methionine). This also translates to a compromised bioavailability and lesser anabolic properties. Studies show that ingestion of a single bolus of a plant protein increases muscle protein synthesis rates to a lesser extent when compared to animal-based proteins.
Combining different types of plant-derived proteins to overcome the amino acid deficiencies has been proposed as a strategy to increase the anabolic properties of plant-derived proteins. However, it is not possible to match the amino acid composition to that of the gold standard, whey protein. Another strategy to improve the anabolic properties of plant-derived proteins is fortification with free essential amino acids. Previously, ingestion of 40g of protein as a lysine fortified meat substitute was shown to increase muscle protein synthesis rates to a similar level as the ingestion of chicken. However, it is unclear whether this similarity was caused by the lysine enrichment or by the ingestion of a really high dose of protein that could have maximized muscle protein synthesis rates. Therefore, the principle of fortification is still to be investigated with the ingestion of a much lower (submaximal, but more realistic) dose of 20g protein.
Therefore, the aim of the current study is to assess postprandial muscle protein synthesis rates in older males in response to ingestion of a blend of plant protein (20g) fortified with free leucine, as compared to the blend of plant protein without additional leucine, and compared to whey protein as the gold standard.
Two primary hypotheses will be tested:
- it is hypothesized that postprandial muscle protein synthesis rates will be higher following ingestion of the fortified plant protein blend when compared to the normal plant protein blend
- it is hypothesized that postprandial muscle protein synthesis rates will be at least as high following ingestion of the fortified plant protein blend when compared to whey protein.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, parallel-group, double-blind, combined superiority non-inferiority, intervention trial
| Arm | Type | Receives |
|---|---|---|
| Fortified plant protein blend | Experimental | Dietary Supplement: Fortified plant-based protein blend20g of plant-based protein blend fortified with 2 g leucine |
| Normal plant protein blend | Experimental | Dietary Supplement: Plant-based protein blend20g of plant-based protein blend |
| Whey protein | Active comparator | Dietary Supplement: Whey protein20g of whey protein |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male sex
- Aged between 60 and 85 y inclusive
- BMI between 18.5 and 35 kg/m2
Key exclusion criteria (16 listed)
- Vegetarian and vegan diet
- Intolerant to milk products
- Soy allergy
- Pea allergy
- Participating in a structured (progressive) exercise program
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 |
|---|---|---|
| Fortified plant-based protein blend20 grams of protein dissolved in 500 mL water from a non-transparent shaker | Dietary supplement | Fortified plant protein blend |
| Plant-based protein blend20 grams of protein dissolved in 500 mL water from a non-transparent shaker | Dietary supplement | Normal plant protein blend |
| Whey protein20 grams of protein dissolved in 500 mL water from a non-transparent shaker | Dietary supplement | Whey protein |
Primary outcome
Postprandial muscle protein fractional synthesic rate
Time frame: 0-4 hours
Muscle protein synthesis rates are calculated using L-ring-13C6-phenylalanine tracer and provided as 1 integrated value over the specified timeframe using plasma as precursor.
4 secondary outcomes
Postabsorptive ('basal') muscle protein fractional synthesis rate
Time frame: -3 - 0 hours
Plasma amino acids concentrations
Time frame: 0-4 hours
Plasma glucose concentrations
Time frame: 0-4 hours
Plasma insulin concentrations
Time frame: 0-4 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 6 May 2025.
- Derived from this study: PubMed 42607838Kuin LME, Hermans WJH, Boot N, Fuchs CJ, Senden JM, Zorenc AH, Overman A, van Kranenburg JMX, Goessens JPB, Verdijk LB, van Dijk M, Furber M, van Helvoort A, van Loon LJC. Ingestion of 20 g of a plant-derived protein blend with and without added leucine or whey protein does not increase muscle protein synthesis rates in older males. J Nutr. 2026 Aug 17:101789. doi: 10.1016/j.tjnut.2026.101789. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Luc van Loon, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified plant-based protein blend, Plant-based protein blend and Whey protein in people with Muscle Protein Synthesis and Sarcopenia, 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 3 inclusion and 16 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 6 May 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 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?
Postprandial muscle protein fractional synthesic rate (time frame: 0-4 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 NCT05711095, 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 6 May 2025.