The Effects of Resistance Training and Protein Supplement... | NCT01004588

Studies
The Effects of Resistance Training and Protein Supplementation in Healthy Elderly Men and Women.

NCT01004588

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Apr 10, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Muscle Loss in Elderly

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 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

Nov 2009

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Oct 26, 2009

First Submission Date that Met QC Criteria

Oct 29, 2009

First Posted Date

Oct 30, 2009Estimated

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 9, 2015

Last Update Posted Date

Apr 10, 2015Estimated

Name	Class
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 main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. For a comprehensive insight into the potential underlying mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad range of tests will be performed before, during, and after the intervention period.

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

60Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein drink	Dietary Supplement	total of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks	Protein drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in muscle mass measured by DXA-scan and CT-scan		0, 12 and 24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over 65 years
healthy men and women

Exclusion Criteria:

cardiovascular disease
COPD
Parkinson
rheumatoid arthritis
musculoskeletal/orthopaedic disorders
cognitive impairment
subjects with metal implants

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

90 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
Marika Leenders, MSc	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		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