Nutritional and Physical Intervention During Bed Rest

NCT ID: NCT07280819

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Muscle Protein Synthetic Response to Protein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a prospective, randomized, parallel-group, controlled interventional trial.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Plant-dominant proteins

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Containing plant-based proteins.

Neuromuscular Electrical Stimulation (NMES)

Intervention Type 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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

Containing animal-based proteins.

Neuromuscular Electrical Stimulation (NMES)

Intervention Type DEVICE

The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min).

Interventions

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

Containing plant-based proteins.

Intervention Type DIETARY_SUPPLEMENT

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

Containing animal-based proteins.

Intervention Type DIETARY_SUPPLEMENT

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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Michèlle Hendriks

Role: CONTACT

+31 43 388 1184

Other Identifiers

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METC 25-020

Identifier Type: -

Identifier Source: org_study_id

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