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

April 9, 2015 updated by: Maastricht University Medical Center

The Effects of Resistance Type Exercise Training and Protein Supplementation on Skeletal Muscle Mass, Strength, and Muscle Characteristics in Healthy Elderly Men and Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Dietary supplement: placebo drink
subjects consume a placebo drink every morning after breakfast over a period of 24 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Top Institute Food and Nutrition

Investigators

  • Principal Investigator: Marika Leenders, MSc, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (ESTIMATE)

October 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEC 09-3-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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