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Not yet recruiting NCT07280819

Nutritional and Physical Intervention During Bed Rest

No phase Interventional Muscle Protein Synthetic Response to Protein

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Muscle Protein Synthetic Response to Protein. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 supplement Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix
    Containing plant-based proteins.
  • Dietary supplement Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix
    Containing animal-based proteins.
  • Device 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).

Primary outcome measures

  • Muscle protein synthesis rate [Time frame: 1-4 days]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Netherlands · 1 center
  • Maastricht University — Maastricht

Identifiers

NCT: NCT07280819 · METC 25-020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗