Single Bout of Resistance Type ExerciseNCT01220037
Resistance Exercise in Healthy Men
A study testing Adhere to a specific standardized diet for 4 days in people with Single Bout of Resistance Type Exercise and Standardized Diet, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Single Bout of Resistance Type Exercise, Standardized Diet
- What is being tested?
- Adhere to a specific standardized diet for 4 days
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men between the ages of 18-30 or 70-85 years
Who cannot join
- Subjects with a recent history or current state of cardiovascular disease, COPD, Parkinson, rheumatoid arthritis, musculoskeletal/orthopaedic disorders, renal disorder, cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Zuid Limburg, 6200MD
About this study
Official title: 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.
- Being tested
- Adhere to a specific standardized diet for 4 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhere to a specific standardized diet for 4 daysBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Young regular diet | Experimental | During the time of the study this group will adhere to a standardized regular diet. Receives: Behavioral: Adhere to a specific standardized diet for 4 days |
| Young low protein diet | Experimental | During the time of the study this group will adhere to a standardized low protein diet. Receives: Behavioral: Adhere to a specific standardized diet for 4 days |
| Young high protein | Experimental | During the time of the study this group will adhere to a standardized high protein diet. Receives: Behavioral: Adhere to a specific standardized diet for 4 days |
| Elderly | Experimental | During the time of the study this group will adhere to a standardized high protein diet Receives: Behavioral: Adhere to a specific standardized diet for 4 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fiber myonuclear and stem cell content
Measured: baseline
Muscle fiber myonuclear and stem cell content
Measured: 12 hours after a single bout of resistance type exercise
Muscle fiber myonuclear and stem cell content
Measured: 24 hours after a single bout of resistance type exercise
Muscle fiber myonuclear and stem cell content
Measured: 48 hours after a single bout of resistance type exercise
Muscle fiber myonuclear and stem cell content
Measured: 72 hours after a single bout resistance type exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single Bout of Resistance Type ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lex Verdijk, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220037
- Sponsor's protocol ID
- MEC 09-3-080
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2010
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Snijders T, Verdijk LB, McKay BR, Smeets JS, van Kranenburg J, Groen BB, Parise G, Greenhaff P, van Loon LJ. Acute dietary protein intake restriction is associated with changes in myostatin expression after a single bout of resistance exercise in healthy young men. J Nutr. 2014 Feb;144(2):137-45. doi: 10.3945/jn.113.183996. Epub 2013 Dec 4.
PubMed 24306214
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Age and Dietary Protein Intake on Myocellular Characteristics Following a Single Bout of Resistance Exercise in Healthy Men
- ClinicalTrials.gov ID
- NCT01220037
- Acronym / sponsor ID
- MEC 09-3-080
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young regular diet | Experimental | Behavioral: Adhere to a specific standardized diet for 4 daysDuring the time of the study this group will adhere to a standardized regular diet. |
| Young low protein diet | Experimental | Behavioral: Adhere to a specific standardized diet for 4 daysDuring the time of the study this group will adhere to a standardized low protein diet. |
| Young high protein | Experimental | Behavioral: Adhere to a specific standardized diet for 4 daysDuring the time of the study this group will adhere to a standardized high protein diet. |
| Elderly | Experimental | Behavioral: Adhere to a specific standardized diet for 4 daysDuring the time of the study this group will adhere to a standardized high protein diet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy men between the ages of 18-30 or 70-85 years
Key exclusion criteria (1 listed)
- Subjects with a recent history or current state of cardiovascular disease, COPD, Parkinson, rheumatoid arthritis, musculoskeletal/orthopaedic disorders, renal disorder, cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhere to a specific standardized diet for 4 days24 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. | Behavioural | Elderly, Young high protein, Young low protein diet, Young regular diet |
Primary outcome
Muscle fiber myonuclear and stem cell content
Time frame: baseline
Muscle fiber myonuclear and stem cell content
Time frame: 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
Muscle fiber myonuclear and stem cell content
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
- Derived from this study: PubMed 24306214Snijders T, Verdijk LB, McKay BR, Smeets JS, van Kranenburg J, Groen BB, Parise G, Greenhaff P, van Loon LJ. Acute dietary protein intake restriction is associated with changes in myostatin expression after a single bout of resistance exercise in healthy young men. J Nutr. 2014 Feb;144(2):137-45. doi: 10.3945/jn.113.183996. Epub 2013 Dec 4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhere to a specific standardized diet for 4 days in people with Single Bout of Resistance Type Exercise and Standardized Diet, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle fiber myonuclear and stem cell content (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013.