Muscle Protein Synthetic Response to ProteinBed-PlantNCT07280819
Nutritional and Physical Intervention During Bed Rest
A study testing Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix, Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix and Neuromuscular Electrical Stimulation (NMES) in people with Muscle Protein Synthetic Response to Protein, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Hospitalization often involves long periods of bed rest and reduced nutritional intake, which can lead to skeletal muscle loss and anabolic resistance. These effects slow recovery and increase the risk of complications, long-term disability and healthcare costs. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Protein Synthetic Response to Protein
- What is being tested?
- Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix, Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix and Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (assessed based on routine medical questionnaire)
- Male and female sexes
- Aged between 18 and 35 years inclusive
- BMI between 18.5 and 30.0 kg/m²
Who cannot join
- Vegan diet
- Allergies or intolerance to cow's milk products, fish, soy, and/or pea protein
- Galactosemia
- Smoking on a weekly basis (i.e., every week)
- Diagnosed diabetes mellitus
- Chronic corticosteroid use
Show all 10Show fewer
- Severe kidney and/or liver failure
- Dialysis
- Bleeding disorders, including anticoagulant and antiplatelet therapy
- Currently pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Protein Source and Neuromuscular Electrical Stimulation on Muscle Protein Synthesis During Bed Rest
Hospitalization often involves long periods of bed rest and reduced nutritional intake, which can lead to skeletal muscle loss and anabolic resistance. These effects slow recovery and increase the risk of complications, long-term disability and healthcare costs. Animal-based proteins are effective at stimulating muscle protein synthesis (MPS) because they contain all essential amino acids and have high bioavailability, but they are less sustainable. Plant-based proteins are more environmentally friendly but may be less effective for MPS due to lower essential amino acid content and lower digestibility. Combining different plant proteins may improve their quality, yet their impact during bed rest is still unclear. Neuromuscular electrical stimulation (NMES) may help counteract anabolic resistance by mimicking exercise, but its long-term effects in bedridden individuals are not well studied.
This prospective, randomized, controlled trial aims to assess the effects of a nutritional intervention (plant-dominant versus dairy-based protein) and a physical stimulus (NMES versus non-NMES) on MPS during 4 days of bed rest in healthy young adults.
- Being tested
- Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix, Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix, Neuromuscular Electrical Stimulation (NMES)
- Keywords
- muscle biopsy, tracer methodology, NMES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mixDietary supplement
Containing plant-based proteins.
Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mixDietary supplement
Containing animal-based proteins.
Neuromuscular Electrical Stimulation (NMES)Device
The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min).
| Study group | Role | What they receive |
|---|---|---|
| Plant-dominant proteins | Experimental | Not described Receives: Dietary Supplement: Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix; Device: Neuromuscular Electrical Stimulation (NMES) |
| Animal-based proteins | Active comparator | Not described Receives: Dietary Supplement: Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix; Device: Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis rate
Muscle protein synthesis rate after 4 day exclusive enteral tube feeding that is nutritionally complete with plant-dominant proteins versus animal-based proteins. This is measured using the deuterated water (2H2O) method.
Measured: 1-4 days
Secondary outcomes (5)
Muscle protein synthesis rate
Muscle protein synthesis rate after NMES versus non-NMES. This is measured using the deuterated water (2H2O) method.
Measured: 1-4 days
Muscle fiber size in µm²
Muscle fiber size will be assessed using immunofluorescence staining.
Measured: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Proportion (%) of muscle fiber types (type I and type II)
Fiber proportion will be assessed using immunofluorescence staining.
Measured: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Myonuclei quantity
Myonuclei quantity will be assessed using immunofluorescence staining.
Measured: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Mitochondrial Respiratory Capacity in Human Skeletal Muscle Assessed by High-Resolution Respirometry
Mitochondrial respiratory capacity will be quantified in skeletal muscle fibers using high-resolution respirometry (Oroboros O2k FluoRespirometer). Measurements will include oxygen flux rates across defined respiratory states.
Measured: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Protein Synthetic Response to ProteinStudies 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
- Parallel groups
- Model description
- The study is a prospective, randomized, parallel-group, controlled interventional trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280819
- Sponsor's protocol ID
- METC 25-020
- Acronym
- Bed-Plant
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Protein Source and Neuromuscular Electrical Stimulation on Muscle Protein Synthesis During Bed Rest
- ClinicalTrials.gov ID
- NCT07280819
- Acronym / sponsor ID
- Bed-Plant / METC 25-020
- Keywords
- muscle biopsy, tracer methodology, NMES
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Dec 2025 (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.
Hospitalization often involves long periods of bed rest and reduced nutritional intake, which can lead to skeletal muscle loss and anabolic resistance. These effects slow recovery and increase the risk of complications, long-term disability and healthcare costs. Animal-based proteins are effective at stimulating muscle protein synthesis (MPS) because they contain all essential amino acids and have high bioavailability, but they are less sustainable. Plant-based proteins are more environmentally friendly but may be less effective for MPS due to lower essential amino acid content and lower digestibility. Combining different plant proteins may improve their quality, yet their impact during bed rest is still unclear. Neuromuscular electrical stimulation (NMES) may help counteract anabolic resistance by mimicking exercise, but its long-term effects in bedridden individuals are not well studied.
This prospective, randomized, controlled trial aims to assess the effects of a nutritional intervention (plant-dominant versus dairy-based protein) and a physical stimulus (NMES versus non-NMES) on MPS during 4 days of bed rest in healthy young adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a prospective, randomized, parallel-group, controlled interventional trial.
| Arm | Type | Receives |
|---|---|---|
| Plant-dominant proteins | Experimental | Dietary Supplement: Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix, Device: Neuromuscular Electrical Stimulation (NMES) |
| Animal-based proteins | Active comparator | Dietary Supplement: Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix, Device: Neuromuscular Electrical Stimulation (NMES) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy (assessed based on routine medical questionnaire)
- Male and female sexes
- Aged between 18 and 35 years inclusive
- BMI between 18.5 and 30.0 kg/m²
Key exclusion criteria (10 listed)
- Vegan diet
- Allergies or intolerance to cow's milk products, fish, soy, and/or pea protein
- Galactosemia
- Smoking on a weekly basis (i.e., every week)
- Diagnosed diabetes mellitus
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 |
|---|---|---|
| Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mixContaining plant-based proteins. | Dietary supplement | Plant-dominant proteins |
| Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mixContaining animal-based proteins. | Dietary supplement | Animal-based proteins |
| Neuromuscular Electrical Stimulation (NMES)The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min). | Device | Animal-based proteins, Plant-dominant proteins |
Primary outcome
Muscle protein synthesis rate
Time frame: 1-4 days
Muscle protein synthesis rate after 4 day exclusive enteral tube feeding that is nutritionally complete with plant-dominant proteins versus animal-based proteins. This is measured using the deuterated water (2H2O) method.
5 secondary outcomes
Muscle protein synthesis rate
Time frame: 1-4 days
Muscle fiber size in µm²
Time frame: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Proportion (%) of muscle fiber types (type I and type II)
Time frame: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Myonuclei quantity
Time frame: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Mitochondrial Respiratory Capacity in Human Skeletal Muscle Assessed by High-Resolution Respirometry
Time frame: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Muscle Protein Synthetic Response to Protein
Recruiting
Diet Synergy in Muscle Protein Synthesis
Muscle Protein Synthetic Response to Protein, Muscle Protein Synthesis
Recruiting
Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU
Critical Illness, Muscle Protein Synthetic Response to Protein
Recruiting
The Effectiveness of a Diet With Beef as Key Protein Component Versus a Plant-Based Diet to Support Integrated Muscle Protein Synthesis Rates in Healthy Older Individuals
Muscle Protein Synthetic Response to Protein
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix, Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix and Neuromuscular Electrical Stimulation (NMES) in people with Muscle Protein Synthetic Response to Protein, 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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michèlle Hendriks (+31 43 388 1184, michelle.hendriks@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis rate (time frame: 1-4 days). 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 12 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.