- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01220037
Resistance Exercise in Healthy Men
October 25, 2013 updated by: Lex Verdijk, Maastricht University Medical Center
The Effect of Age and Dietary Protein Intake on Myocellular Characteristics Following a Single Bout of Resistance Exercise in Healthy Men
In the present study, the effects of age and dietary intake will be assessed on myocellular characteristics during 72 hours after a resistance type exercise session.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
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
-
-
Zuid Limburg
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Maastricht, Zuid Limburg, Netherlands, 6200MD
- Maastricht University Medical Centre
-
-
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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy men between the ages of 18-30 or 70-85 years
Exclusion Criteria:
- Subjects with a recent history or current state of cardiovascular disease, COPD, Parkinson, rheumatoid arthritis, musculoskeletal/orthopaedic disorders, renal disorder, cognitive impairment.
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Young regular diet
During the time of the study this group will adhere to a standardized regular diet.
|
24 h before the start of the intervention all subjects will adhere to a standardized diet for 4 days.
Young subjects are randomly allocated to either a low protein diet, regular protein diet or high protein diet group.
All elderly subjects will adhere to a regular protein diet comparable to the regular protein diet of the young subjects.
|
|
Experimental: Young low protein diet
During the time of the study this group will adhere to a standardized low protein diet.
|
24 h before the start of the intervention all subjects will adhere to a standardized diet for 4 days.
Young subjects are randomly allocated to either a low protein diet, regular protein diet or high protein diet group.
All elderly subjects will adhere to a regular protein diet comparable to the regular protein diet of the young subjects.
|
|
Experimental: Young high protein
During the time of the study this group will adhere to a standardized high protein diet.
|
24 h before the start of the intervention all subjects will adhere to a standardized diet for 4 days.
Young subjects are randomly allocated to either a low protein diet, regular protein diet or high protein diet group.
All elderly subjects will adhere to a regular protein diet comparable to the regular protein diet of the young subjects.
|
|
Experimental: Elderly
During the time of the study this group will adhere to a standardized high protein diet
|
24 h before the start of the intervention all subjects will adhere to a standardized diet for 4 days.
Young subjects are randomly allocated to either a low protein diet, regular protein diet or high protein diet group.
All elderly subjects will adhere to a regular protein diet comparable to the regular protein diet of the young subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Muscle fiber myonuclear and stem cell content
Time Frame: baseline
|
baseline
|
|
Muscle fiber myonuclear and stem cell content
Time Frame: 12 hours after a single bout of resistance type exercise
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12 hours after a single bout of resistance type exercise
|
|
Muscle fiber myonuclear and stem cell content
Time Frame: 24 hours after a single bout of resistance type exercise
|
24 hours after a single bout of resistance type exercise
|
|
Muscle fiber myonuclear and stem cell content
Time Frame: 48 hours after a single bout of resistance type exercise
|
48 hours after a single bout of resistance type exercise
|
|
Muscle fiber myonuclear and stem cell content
Time Frame: 72 hours after a single bout resistance type exercise
|
72 hours after a single bout resistance type exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
October 7, 2010
First Submitted That Met QC Criteria
October 12, 2010
First Posted (Estimate)
October 13, 2010
Study Record Updates
Last Update Posted (Estimate)
October 28, 2013
Last Update Submitted That Met QC Criteria
October 25, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- MEC 09-3-080
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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