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Nutritional and Physical Intervention During Bed Rest

The Impact of Protein Source and Neuromuscular Electrical Stimulation on Muscle Protein Synthesis During Bed Rest

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07280819
Acronym
Bed-Plant
Enrollment
20
Registered
2025-12-12
Start date
2026-01-31
Completion date
2029-01-31
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Protein Synthetic Response to Protein

Keywords

muscle biopsy, tracer methodology, NMES

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTNutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix

Containing plant-based proteins.

DIETARY_SUPPLEMENTNutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix

Containing animal-based proteins.

DEVICENeuromuscular Electrical Stimulation (NMES)

The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min).

Sponsors

Danone Global Research & Innovation Center
CollaboratorINDUSTRY
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

The study is a prospective, randomized, parallel-group, controlled interventional trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * Severe kidney and/or liver failure * Dialysis * Bleeding disorders, including anticoagulant and antiplatelet therapy * Currently pregnant

Design outcomes

Primary

MeasureTime frameDescription
Muscle protein synthesis rate1-4 daysMuscle 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.

Secondary

MeasureTime frameDescription
Muscle fiber size in µm²Final intervention day (after 4 days of enteral feeding and 4 days of NMES)Muscle fiber size will be assessed using immunofluorescence staining.
Muscle protein synthesis rate1-4 daysMuscle protein synthesis rate after NMES versus non-NMES. This is measured using the deuterated water (2H2O) method.
Proportion (%) of muscle fiber types (type I and type II)Final intervention day (after 4 days of enteral feeding and 4 days of NMES)Fiber proportion will be assessed using immunofluorescence staining.
Myonuclei quantityFinal intervention day (after 4 days of enteral feeding and 4 days of NMES)Myonuclei quantity will be assessed using immunofluorescence staining.
Mitochondrial Respiratory Capacity in Human Skeletal Muscle Assessed by High-Resolution RespirometryFinal intervention day (after 4 days of enteral feeding and 4 days of NMES)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.

Other

MeasureTime frameDescription
Height in mBaselineHeteroanamnesia
BMI in kg/m²BaselineCalculated from height and body mass
Body mass in kgBaselineHeteroanamnesia
Age in yearsBaselineHeteroanamnesia

Countries

Netherlands

Contacts

Primary ContactMichèlle Hendriks
michelle.hendriks@maastrichtuniversity.nl+31 43 388 1184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026