跳至主要内容
临床试验/NCT07062562
NCT07062562招募中不适用

The Effect of Repeated Sessions of Whole-body Neuromuscular Electrical Stimulation (NMES), With or Without Subsequent Intake of a Protein Bolus, on Muscle Protein Synthesis in Healthy, Young Volunteers During 3 Days of Bed Rest

Wageningen University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Cumulative myofibrillar fractional synthesis rate

研究概览

简要总结

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.

详细描述

Patients admitted to the hospital often experience prolonged bed rest, which can lead to rapid muscle loss and weakness. In the intensive care unit (ICU), this condition, known as ICU-acquired weakness (ICU-AW), affects up to 50% of patients and can lead to longer mechanical ventilation times, increased morbidity, and a reduced quality of life after hospital discharge. One of the key reasons for muscle loss during bed rest is an impaired response to dietary protein, which normally helps maintain muscle mass.

Neuromuscular electrical stimulation (NMES) is a method that uses small electrical currents to stimulate muscle contractions, potentially counteracting muscle loss during periods of inactivity. Previous research has shown that NMES applied to the quadriceps muscles can reduce muscle loss in sedated patients and improve muscle protein synthesis in individuals with type 2 diabetes. However, the effects of whole-body NMES in combination with timed protein intake on muscle protein metabolism during bed rest are still unknown.

This study aims to investigate the impact of both a single session and repeated sessions of whole-body NMES, with or without subsequent protein intake, on muscle protein synthesis rates, muscle mass, and function during 3 days of bed rest in healthy young adults.

Study Design:

This is a randomized, placebo-controlled clinical trial with three parallel groups. Participants will be randomly assigned to one of the following groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Employed or undertaking a thesis or internship at the department of Human and Animal Physiology at Wageningen University
  • •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
  • •Presence of an ulcer in the stomach or gut and/or strong history of indigestion
  • •Contra-indications for DXA scans (e.g. undergoing radiologic examination)
  • •Lactose intolerance
  • •Known severe kidney problems
  • •Pregnant or breastfeeding
  • •Unable to give consent

研究组 & 干预措施

Control group

Sham Comparator

Sham-NMES with standard nutrition

干预措施: Sham (No Treatment) (Other)

Control group

Sham Comparator

Sham-NMES with standard nutrition

干预措施: Standard nutrition (Other)

Whole-body NMES group

Active Comparator

Whole-body NMES stimulation with standard nutrition

干预措施: NMES (Other)

Whole-body NMES group

Active Comparator

Whole-body NMES stimulation with standard nutrition

干预措施: Standard nutrition (Other)

Whole-body NMES + protein group

Active Comparator

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

干预措施: Standard nutrition (Other)

Whole-body NMES + protein group

Active Comparator

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

干预措施: NMES (Other)

Whole-body NMES + protein group

Active Comparator

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

干预措施: Protein bolus (20g) (Dietary Supplement)

结局指标

主要结局

Cumulative myofibrillar fractional synthesis rate

时间窗: 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),

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

次要结局

  • 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)
  • Handgrip Strength(Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6)
  • Whole-Body Nitrogen Balance(Day 0 to Day 3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marlou Dirks

Assistant Professor

Wageningen University

研究点 (1)

Loading locations...

相似试验

The Effect of Repeated Whole-body NMES Sessions With... | 临床试验