Healthy SubjectsNCT01325038
Effects of Increased Muscle Mass on Resting Metabolic Rate
A study testing Isometric exercise in people with Healthy Subjects, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Healthy males are randomized to isometric exercise for three months with either extra protein or extra calories in the form of a fast food meal/day in order to study if increase in muscle mass increases resting metabolic rate and if this is affected by presumed increased caloric intake as compared with only proteins. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Isometric exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Aug 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
Who cannot join
- significant disease
- inability to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Healthy males are randomized to isometric exercise for three months with either extra protein or extra calories in the form of a fast food meal/day in order to study if increase in muscle mass increases resting metabolic rate and if this is affected by presumed increased caloric intake as compared with only proteins.
Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured by registration of CO2 production and O2 consumption.
- Conditions
- Healthy Subjects
- Being tested
- Isometric exercise
- Keywords
- resting metabolic rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseProcedure or surgery
Isometric exercise several times/week for three months
| Study group | Role | What they receive |
|---|---|---|
| extra protein supplement | Active comparator | isometric training with addition of extra protein Receives: Procedure: Isometric exercise |
| extra food supplement | Active comparator | isometric exercise with addition of extra food and calories: one fast food meal/day Receives: Procedure: Isometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in resting metabolic rate
measurement of resting metabolic rate at baseline and at the end of the three month trial period
Measured: 3 months
Secondary outcomes (1)
change in muscle mass
measurement of muscle mass with DEXA at baseline and at the end of the three month trial period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionAug 2009
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 Healthy SubjectsStudies 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325038
- Sponsor's protocol ID
- Beach08
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hambre D, Vergara M, Lood Y, Bachrach-Lindstrom M, Lindstrom T, Nystrom FH. A randomized trial of protein supplementation compared with extra fast food on the effects of resistance training to increase metabolism. Scand J Clin Lab Invest. 2012 Oct;72(6):471-8. doi: 10.3109/00365513.2012.698021. Epub 2012 Aug 30.
PubMed 22935042
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Increased Muscle Mass on Resting Metabolic Rate
- ClinicalTrials.gov ID
- NCT01325038
- Acronym / sponsor ID
- Beach08
- Conditions
- Healthy Subjects
- Keywords
- resting metabolic rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 29 Mar 2011 (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.
Healthy males are randomized to isometric exercise for three months with either extra protein or extra calories in the form of a fast food meal/day in order to study if increase in muscle mass increases resting metabolic rate and if this is affected by presumed increased caloric intake as compared with only proteins.
Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured by registration of CO2 production and O2 consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extra protein supplement | Active comparator | Procedure: Isometric exerciseisometric training with addition of extra protein |
| extra food supplement | Active comparator | Procedure: Isometric exerciseisometric exercise with addition of extra food and calories: one fast food meal/day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy males
Key exclusion criteria (2 listed)
- significant disease
- inability to exercise
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 |
|---|---|---|
| Isometric exerciseIsometric exercise several times/week for three months | Procedure or surgery | extra food supplement, extra protein supplement |
Primary outcome
change in resting metabolic rate
Time frame: 3 months
measurement of resting metabolic rate at baseline and at the end of the three month trial period
1 secondary outcome
change in muscle mass
Time frame: 3 months
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 29 Mar 2011.
- Derived from this study: PubMed 22935042Hambre D, Vergara M, Lood Y, Bachrach-Lindstrom M, Lindstrom T, Nystrom FH. A randomized trial of protein supplementation compared with extra fast food on the effects of resistance training to increase metabolism. Scand J Clin Lab Invest. 2012 Oct;72(6):471-8. doi: 10.3109/00365513.2012.698021. Epub 2012 Aug 30.
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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 Isometric exercise in people with Healthy Subjects, run by University Hospital, Linkoeping at 1 site in Sweden.
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 2 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 29 Mar 2011. 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 Sweden. 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?
change in resting metabolic rate (time frame: 3 months). 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 NCT01325038, 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 29 Mar 2011.