Nutritional and Physical Intervention During Bed Rest

NCT07280819 | Not Yet Recruiting

• 1 other identifier: METC 25-020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Protein Synthetic Response to Protein

Keywords

muscle biopsy; tracer methodology; NMES

Outcome Measures

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.

  1-4 days

Secondary Outcomes (5)

• Muscle protein synthesis rate

  1-4 days

• Muscle fiber size in µm²

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

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

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

• Myonuclei quantity

  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

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

Other Outcomes (4)

• Age in years

  Baseline

• Body mass in kg

  Baseline

• Height in m

  Baseline

Study Arms (2)

Plant-dominant proteins

EXPERIMENTAL

Dietary Supplement: Nutritionally complete tube feed providing a sole source of nutrition with a plant-dominant protein mix; Device: Neuromuscular Electrical Stimulation (NMES)

Animal-based proteins

ACTIVE COMPARATOR

Dietary Supplement: Nutritionally complete tube feed providing a sole source of nutrition with an animal-based protein mix; Device: Neuromuscular Electrical Stimulation (NMES)

Interventions

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).

Animal-based proteins; Plant-dominant proteins

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

Containing plant-based proteins.

Plant-dominant proteins

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

Containing animal-based proteins.

Animal-based proteins

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Maastricht University

Maastricht, 6200 MD, Netherlands

Location

Central Study Contacts

Michèlle Hendriks

CONTACT

+31 43 388 1184; michelle.hendriks@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)