Protein Supplementation to Promote Muscle Protein Anaboli... | NCT01109628

Studies
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People

NCT01109628

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Apr 4, 2025Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Sarcopenia

Interventions

Protein drink
Placebo drink

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

Apr 2025

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

Nov 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Apr 21, 2010

First Posted Date

Apr 23, 2010Estimated

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

Apr 1, 2025

Last Update Posted Date

Apr 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lisette de Groot, Professor, Wageningen UniversityPrincipal Investigator

Lead Sponsor

Wageningen UniversityOTHER

Collaborators

Name	Class
Maastricht University Medical Center	OTHER
Top Institute Food and Nutrition	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.

Detailed Description

Not provided

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

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Protein drink	Experimental		Dietary Supplement: Protein drink
Placebo drink	Placebo Comparator		Dietary Supplement: Placebo drink

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein drink	Dietary Supplement	Twice a day during 6 months	Protein drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in skeletal muscle mass		Baseline, 3 months and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Physical performance		Baseline, 3 months and 6 months
Blood parameters related to the outcome measures		Baseline, 3 months and 6 months
Dietary intake

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Frail elderly individuals
Able to understand and perform the study procedures

Exclusion Criteria:

Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)
No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)
Use of anti-coagulation medication (except of Acetyl Salicyl acid)
Renal insufficiency (eGFR <60 mL/min/1.73 m2)
Allergic or sensitive for milk proteins

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wageningen University		Wageningen	Gelderland	6703HD	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24374288	Derived	van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
24045855

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