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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01004588
First received: October 26, 2009
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Muscle Loss in Elderly
 Dietary Supplement: Protein drink
Dietary Supplement: placebo drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Resistance Type Exercise Training and Protein Supplementation on Skeletal Muscle Mass, Strength, and Muscle Characteristics in Healthy Elderly Men and Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Change in muscle mass measured by DXA-scan and CT-scan [ Time Frame: 0, 12 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein drink
protein drink
 Dietary Supplement: Protein drink
total of 15 g protein/d in a protein drink consumed every morning after breakfast during 24 weeks
Placebo Comparator: Placebo drink
Placebo drink
 Dietary Supplement: placebo drink
subjects consume a placebo drink every morning after breakfast over a period of 24 weeks.

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004588

Locations
Netherlands
Maastricht University
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: Marika Leenders, MSc Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01004588     History of Changes
Other Study ID Numbers: MEC 09-3-056
Study First Received: October 26, 2009
Last Updated: November 14, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
elderly
sarcopenia
protein drink
resistance training

ClinicalTrials.gov processed this record on May 21, 2013