The Effect of Repeated Whole-body NMES Sessions With or Without Protein Intake on Muscle Protein Synthesis During 3 Days of Bed Rest in Healthy Young Volunteers

NCT07062562 | Recruiting

• 1 other identifier: NL88628.028.24
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine the effect of whole-body electrostimulation with protein intake on muscle protein synthesis, muscle mass and function during bed rest in healthy young adults (18-35 years). The main questions to answer are:

• Does whole-body NMES followed by protein intake improve muscle protein synthesis rates during 3 days of bed rest?
• Does repeated NMES sessions offer protective effects on muscle mass and function during extended periods of inactivity? Researchers will compare sham electrical electrostimulation, electrical stimulation and electrical stimulation + protein groups to see if whole-body electrostimulation combined with protein intake offers the greatest improvement in muscle protein metabolism and muscle preservation. Participants will:
• Undergo 3 days of bed rest while receiving one of the following interventions:
• Sham-NMES followed by standard nutrition (CON)
• Whole-body NMES followed by standard nutrition(NMES)
• Whole-body NMES followed by a bolus of 20g protein (NMES+PRO)
• Receive heavy water (D2O) to assess body water turnover.
• Undergo leg extension exercises to assess muscle function.
• Have quadriceps muscle thickness measured via ultrasound.
• Provide saliva samples for analysis.
• Have calf circumference measured to monitor changes in muscle mass.

Conditions

Muscle Wasting

Keywords

NMES; Skeletal Muscle Metabolism; Protein; Disuse

Outcome Measures

Primary Outcomes (1)

• Cumulative myofibrillar fractional synthesis rate

  A measure of muscle protein synthesis between two given time points.

  Habitual MPS (Day -2 to Day 0), Acute effect of NMES (+protein bolus) (0 hours to 5 hours on Day 0), Bedrest MPS (Day 0 to Day 3),

Secondary Outcomes (7)

• Quadriceps Muscle Layer Thickness

  Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6

• Body Composition

  Day 0 and Day 3.

• Body composition

  Time Frame: Day 0 and Day 3.

• Quadriceps Muscle Function

  Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6

• Quadriceps Muscle Strength

  Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6

Study Arms (3)

Control group

SHAM COMPARATOR

Sham-NMES with standard nutrition

Other: Sham (No Treatment); Other: Standard nutrition

Whole-body NMES group

ACTIVE COMPARATOR

Whole-body NMES stimulation with standard nutrition

Other: NMES; Other: Standard nutrition

Whole-body NMES + protein group

ACTIVE COMPARATOR

Whole-body NMES with a 20g protein bolus on top of the standard nutrition

Other: NMES; Dietary Supplement: Protein bolus (20g); Other: Standard nutrition

Interventions

Sham (No Treatment) OTHER

A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.

Control group

NMES OTHER

Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.

Whole-body NMES + protein group; Whole-body NMES group

Protein bolus (20g) DIETARY_SUPPLEMENT

A bolus dose of 20 grams of protein provided after the NMES intervention to assess the combined effect of muscle stimulation and protein intake on muscle protein metabolism.

Whole-body NMES + protein group

Standard nutrition OTHER

Provision of a normal Western standardized diet.

Control group; Whole-body NMES + protein group; Whole-body NMES group

Eligibility Criteria

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

You may qualify if:

• Aged from 18-35 years
• \< BMI \< 30 kg·m2
• Recreationally active (performing non-competitive physical exercise at least one time per week for minimally 30 minutes)

You may not qualify if:

• Employed or undertaking a thesis or internship at the department of Human and Animal Physiology at Wageningen University
• Smoking
• Diabetes (Type 1, Type 2, or genetic form of diabetes)
• Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or
• ≥90 mmHg diastolic)
• Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
• Known allergy to lidocaine
• Prone to keloid forming (i.e. hyperplastic growth of scars)
• All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g.
• arthritis, spasticity/rigidity, all neurological disorders and paralysis)
• Regular use of dietary protein and/or amino acid supplements (\>3 times per week)
• Currently involved in a structured progressive resistance training programme (\>3 times per week)
• A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia
• Any previous motor disorders or disorders in muscle and/or lipid metabolism
• Any back, leg, knee, neck, shoulder or postural complaints

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6708WD, Netherlands

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Marlou Dirks, PhD

CONTACT

+31 317 480 100; marlou.dirks@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a randomized, placebo-controlled intervention trial with three parallel groups. Participants will undergo 3 days of bed rest and receive either sham-NMES, whole-body NMES, or whole-body NMES with protein to assess the effects on muscle protein synthesis. The study will measure muscle protein metabolism, strength, and function to determine whether NMES and protein intake can mitigate muscle loss during immobilization.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 14, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

NL (1)