Skeletal Muscle Mass RegulationPhase 2NSAID2015NCT02531451
The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults
A Phase 2 study testing Ibuprofen and Acetylsalicylic acid in people with Skeletal Muscle Mass Regulation, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Mass Regulation
- What is being tested?
- Ibuprofen and Acetylsalicylic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 2
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Considered healthy
- Moderately trained
- 18-35 yrs
Who cannot join
- Cardiovascular disease
- Impaired kidney or liver function
- Lower limb injury
- Pregnancy
- Ulcer or gastrointestinal upsets
- Previous reactions to use of NSAID
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise
In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Before and after training, muscle volume is measured by MRI, and muscle strength is assessed by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus lateralis to study gene and protein expression of markers regulating muscle protein turnover and prostaglandin synthesis.
- Conditions
- Skeletal Muscle Mass Regulation
- Being tested
- Ibuprofen, Acetylsalicylic acid
- Keywords
- Muscle mass, strength, NSAID, Ibuprofen, resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Acetylsalicylic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Resistance exercise 20 sessions during 8 weeks Daily consumption of 1200 mg ibuprofen (400 mg x 3) during 8 weeks Receives: Drug: Ibuprofen |
| Acetylsalicylic acid | Active comparator | Resistance exercise 20 sessions during 8 weeks Daily consumption of 75 mg acetylsalicylic acid (75 mg x 1) during 8 weeks Receives: Drug: Acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps muscle volume
Measured through MRI
Measured: Baseline and after 8 weeks training
Secondary outcomes (3)
Change in muscle gene expression
Through quantitative PCR and microarray
Measured: Baseline, 4 weeks and after 8 weeks training
Change in muscle protein expression
Through Western Blots
Measured: Baseline, 4 weeks and after 8 weeks training
Change in Quadriceps muscle strength
Measured in strength dynamometers
Measured: Baseline and after 8 weeks training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle Mass RegulationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommy Lundberg, Karolinska Institutet
- Investigators
- Tommy Lundberg, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531451
- Sponsor's protocol ID
- 2014-004872-47
- Other IDs
- 2014
- Acronym
- NSAID2015
- Status last verified
- Jun 2016
- First submitted
- 19 Aug 2015
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise
- ClinicalTrials.gov ID
- NCT02531451
- Acronym / sponsor ID
- NSAID2015 / 2014-004872-47
- Conditions
- Skeletal Muscle Mass Regulation
- Keywords
- Muscle mass, strength, NSAID, Ibuprofen, resistance exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Aug 2015 (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 this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Before and after training, muscle volume is measured by MRI, and muscle strength is assessed by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus lateralis to study gene and protein expression of markers regulating muscle protein turnover and prostaglandin synthesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: IbuprofenResistance exercise 20 sessions during 8 weeks Daily consumption of 1200 mg ibuprofen (400 mg x 3) during 8 weeks |
| Acetylsalicylic acid | Active comparator | Drug: Acetylsalicylic acidResistance exercise 20 sessions during 8 weeks Daily consumption of 75 mg acetylsalicylic acid (75 mg x 1) during 8 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Considered healthy
- Moderately trained
- 18-35 yrs
Key exclusion criteria (6 listed)
- Cardiovascular disease
- Impaired kidney or liver function
- Lower limb injury
- Pregnancy
- Ulcer or gastrointestinal upsets
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 |
|---|---|---|
| Ibuprofen | Drug | Ibuprofen |
| Acetylsalicylic acid | Drug | Acetylsalicylic acid |
Primary outcome
Change in Quadriceps muscle volume
Time frame: Baseline and after 8 weeks training
Measured through MRI
3 secondary outcomes
Change in muscle gene expression
Time frame: Baseline, 4 weeks and after 8 weeks training
Change in muscle protein expression
Time frame: Baseline, 4 weeks and after 8 weeks training
Change in Quadriceps muscle strength
Time frame: Baseline and after 8 weeks training
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 Jun 2016.
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.
Tommy Lundberg, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen and Acetylsalicylic acid in people with Skeletal Muscle Mass Regulation, run by Karolinska Institutet 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 3 inclusion and 6 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 Jun 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Quadriceps muscle volume (time frame: Baseline and after 8 weeks training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2016.