- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280819
Nutritional and Physical Intervention During Bed Rest (Bed-Plant)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michèlle Hendriks
- Phone Number: +31 43 388 1184
- Email: michelle.hendriks@maastrichtuniversity.nl
Study Locations
-
-
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Maastricht, Netherlands, 6200 MD
- Maastricht University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Plant-dominant proteins
|
Containing plant-based proteins.
The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min).
|
|
Active Comparator: Animal-based proteins
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The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min).
Containing animal-based proteins.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1-4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle protein synthesis rate
Time Frame: 1-4 days
|
Muscle protein synthesis rate after NMES versus non-NMES.
This is measured using the deuterated water (2H2O) method.
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1-4 days
|
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Muscle fiber size in µm²
Time Frame: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
|
Muscle fiber size will be assessed using immunofluorescence staining.
|
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)
|
Fiber proportion will be assessed using immunofluorescence staining.
|
Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
|
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Myonuclei quantity
Time Frame: Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
|
Myonuclei quantity will be assessed using immunofluorescence staining.
|
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)
|
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.
|
Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age in years
Time Frame: Baseline
|
Heteroanamnesia
|
Baseline
|
|
Body mass in kg
Time Frame: Baseline
|
Heteroanamnesia
|
Baseline
|
|
Height in m
Time Frame: Baseline
|
Heteroanamnesia
|
Baseline
|
|
BMI in kg/m²
Time Frame: Baseline
|
Calculated from height and body mass
|
Baseline
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- METC 25-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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