NMES During the Day and Prior to Sleep | NCT02253329

Studies
NMES During the Day and Prior to Sleep

NCT02253329

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

May 21, 2015Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Sarcopenia

Interventions

Dietary protein plus NMES during the day
Dietary protein plus NMES prior to sleep

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Sep 29, 2014

First Submission Date that Met QC Criteria

Sep 29, 2014

First Posted Date

Oct 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2015

Last Update Posted Date

May 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep

Detailed Description

In the present study, the effect of a bolus of intrinsically labeled milk directly after an hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and immediately prior to sleep

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment during the day	Active Comparator	Neuromuscular electrical stimulation after a protein bolus, performed during the day	Procedure: Dietary protein plus NMES during the day
Treatment prior to sleep	Active Comparator	Protein ingestion directly after one-legged NMES, directly prior to sleep	Procedure: Dietary protein plus NMES prior to sleep

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary protein plus NMES during the day	Procedure	Neuromuscular electrical stimulation after a protein bolus, performed during the day	Treatment during the day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incorporation of stable isotope amino acids into skeletal muscle tissue		4-8 hours in the postprandial phase

Secondary Outcomes

Measure	Description	Time Frame
Plasma amino acid enrichment		4-8 hours in the postprandial phase

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 65-85 years
Male
18.5 ≤ BMI ≤ 30.0

Exclusion Criteria:

Type II diabetes
All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery).
Use of anticoagulants, blood diseases, allergy for lidocaine
Use of NSAIDs (non-steroidal anti-inflammatory drugs) and acetylsalicylic acid
Patients suffering from PKU (Phenylketonuria)
Presence of implantable cardioverter defibrillator and/or pacemaker
Performed regular resistance type exercise in the past 6 months
Use of any tools to assist during walking (cane/ crutches/ walker)
(Partial) foot/ leg amputation

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luc JC van Loon, PhD	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Centre +		Maastricht			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004044	Dietary Proteins

Ancestor Terms

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D005502	Food
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided