Nutritional and Physical Intervention During Bed Rest

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Plant-dominant proteinsExperimental treatment 2 interventions
Group B: Animal-based proteinsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1-4 days

Secondary outcomes

1

Muscle protein synthesis rate

Muscle protein synthesis rate after NMES versus non-NMES. This is measured using the deuterated water (2H2O) method.

Time frame
1-4 days
2

Muscle fiber size in µm²

Muscle fiber size will be assessed using immunofluorescence staining.

Time frame
Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
3

Proportion (%) of muscle fiber types (type I and type II)

Fiber proportion will be assessed using immunofluorescence staining.

Time frame
Final intervention day (after 4 days of enteral feeding and 4 days of NMES)
4

Myonuclei quantity

Myonuclei quantity will be assessed using immunofluorescence staining.

Time frame
Final intervention day (after 4 days of enteral feeding and 4 days of NMES)

Other outcomes

1

Age in years

Heteroanamnesia

Time frame
Baseline
2

Body mass in kg

Heteroanamnesia

Time frame
Baseline
3

Height in m

Heteroanamnesia

Time frame
Baseline
4

BMI in kg/m²

Calculated from height and body mass

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University Medical Center

Lead sponsor

Danone Global Research & Innovation Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: