NCT01004588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

October 26, 2009

Last Update Submit

April 9, 2015

Conditions

Muscle Loss in Elderly

Keywords

elderlysarcopeniaprotein drinkresistance training

Outcome Measures

Primary Outcomes (1)

  • Change in muscle mass measured by DXA-scan and CT-scan

    0, 12 and 24 weeks

Study Arms (2)

Protein drink

EXPERIMENTAL

protein drink

Dietary Supplement: Protein drink

Placebo drink

PLACEBO COMPARATOR

Placebo drink

Dietary Supplement: placebo drink

Interventions

Protein drinkDIETARY_SUPPLEMENT

total of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks

Protein drink
placebo drinkDIETARY_SUPPLEMENT

subjects consume a placebo drink every morning after breakfast over a period of 24 weeks.

Placebo drink

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • over 65 years
  • healthy men and women

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Marika Leenders, MSc

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 30, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

NL(1)