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NCT Number: NCT07280819

Nutritional and Physical Intervention 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.

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Key information

Conditions

Muscle Protein Synthetic Response to Protein

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

Containing plant-based proteins.

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

Dietary 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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. Age in years

    Time frame: Baseline

    Heteroanamnesia

  2. Body mass in kg

    Time frame: Baseline

    Heteroanamnesia

  3. Height in m

    Time frame: Baseline

    Heteroanamnesia

  4. BMI in kg/m²

    Time frame: Baseline

    Calculated from height and body mass

Study contacts

Contact information is provided by the study sponsor or research team.

Michèlle Hendriks

CONTACT

[email protected]

+31 43 388 1184

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Danone Global Research & Innovation Center

Registry information

Official study title

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

Acronym: Bed-Plant

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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