Muscle FatigueNCT02014233
Short Term Omega-3 Supplementation on Performance
A study testing Omega-3 and Olive oil in people with Muscle Fatigue and Muscle Strength, run by University of Toronto at 1 site in Canada.
Trial summary
Nerves are the rate limiting factor that control muscle function. However, it is unknown if a nutritional supplement can change the nerve-muscle interaction, and therefore alter human performance. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue, Muscle Strength
- What is being tested?
- Omega-3 and Olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Mar 2014
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 2 years training experience that includes resistance training, specifically back squat
- Successfully completing a Par-Q questionnaire
Who cannot join
- Individuals that have or are currently taking an omega-3 and/or omega-6 supplement within 4 weeks of the study
- Individuals that have taken mammalian based omega-3 or 6 supplements in the past 6 months
- Individuals consuming fish more than twice per week within 4 weeks of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Short Term Omega-3 Supplementation on Exercise Performance and Neuromuscular Function.
Nerves are the rate limiting factor that control muscle function. However, it is unknown if a nutritional supplement can change the nerve-muscle interaction, and therefore alter human performance. This study will be the first to examine the effects of omega-3 supplementation on neuromuscular function in trained individuals.
Read the detailed description
Participants will come to the lab for 3 sessions, one for familiarization and two for testing.
Familiarization - At this time, anthropometric measurements including height, weight, BMI (body mass index) and body composition will be determined. Participants will be familiarized with the interpolated twitch technique and performing a maximal voluntary contraction of the quadriceps muscle. Next, Participant's 10 repetition maximum squat weight will be established by starting at a participant selected weight and gradually increasing until only 10 squat repetitions can be completed. A VO2max (maximum oxygen consumption) test will be performed on a cycle ergometer using standard methods.
On testing sessions 1 and 2 the following neuromuscular and performance measures will be evaluated:
- Quadriceps muscle voluntary activation will be assessed using the interpolated twitch technique and doublet twitch technique. Participants will be seated and instructed to perform three 5 second maximal voluntary isometric contractions at least 1 minute apart - participant's ankle will be restrained by a padded cuff attached to a load cell. For the second maximal isometric contraction at 3 seconds into the contraction, a square wave superimposed stimulus will be delivered for 1 milliseconds to the femoral nerve from a monopolar touch-proof cathode electrode secured in the femoral triangle. 2, 7 and 12 seconds after the contraction a resting twitch will be delivered for comparison of muscle force. For the third maximal isometric contraction, at 3 seconds into the contraction, two 1 millisecond square wave superimposed stimuli at 100 Hz will be delivered 10 milliseconds apart. 2 seconds after the contraction the same stimulus will be applied. At 7 seconds after, two stimuli will be delivered 100 milliseconds at 10 Hz apart and 12 seconds after a single stimulus will be delivered. The percutaneous electrical stimulation will be delivered from a Biopac stimulator (BSLSTMA, Biopac Systems, Santa Barbara, California) with a maximum voltage of 400 V. During familiarization, participants will receive several submaximal stimulations for acclimatization before the current intensity is gradually increased until peak twitch torque and muscle action potential amplitude is reached. A stimulus of 1.2 times the current required to elicit peak twitch torque and action potential amplitude will be used to ensure maximal activation. The interpolated twitch technique will be used to examine the difference in muscle activation during maximal contraction and a superimposed stimulation. Voluntary activation will be calculated using the formula: Voluntary activation (%) = (1- superimposed twitch / twitch evoked at rest) x 100 Surface self-adhesive silver chloride electrodes will be placed over the belly of the vastus lateralis, vastus medialis and biceps femoris muscles to measure muscle electrical activity (electromyography) during maximal voluntary contractions as previously described.
- Vertical jump - Quadriceps power will be assessed using the vertical jump test on a force plate (AMTI, Watertown, Massachusetts, USA). Participants will complete two attempts to jump as high as possible from crouched and two attempts using the counter jump technique (participants can start from standing, bend the knees and then jump).
- Push-up - Upper body strength endurance will be examined by having the participant complete as many push-ups as possible in one-minute. Participants will be given one-minute rest before being asked to complete as many push-ups as possible in a minute. A piece of soft foam will be attached to the floor to provide participants feedback as to how low the must go when performing each push-up.
- 10RM (10 repetition maximum) squat - After completing an optional 2 to 4 repetitions of 75% of the their 10RM weight as determined during baseline data collection, participants will complete as many repetitions as possible.
- Wingate test - Participants will be fitted to a cycle ergometer (Excalibur Sport V2.0, Lode, Groningen, The Netherlands). They will then cycle against a fixed resistance of 0.075kg / kg body mass for 30 seconds using their maximum effort. Verbal encouragement will be provided to the participant to help produce their maximum effort.
- Cycling time trial - Participants will complete a 10km time trial on a cycle ergometer (Excalibur Sport V2.0, Lode, Groningen, The Netherlands). Participants' inspired and expired gasses will be measured using a metabolic cart (Cortex, Leipzig, Germany). Gas variables and cycling power output will be measured using the supplied software. This change in protocol does not alter the risk to participants as their level of conditioning is quite high and similar levels of exertion would be required in their daily training.
Supplementation - In between sessions 1 and 2, there is a 21 day break for which participants will be computer randomized to either the omega-3 supplementation or an olive oil placebo. Participants will take a 2.5 mL serving of seal oil (2500 mg n-3, 255 mg DHA (docosahexaenoic acid ) and 187.5 mg EPA (eicosapentaenoic acid) with 500 IU vitamin D3 and 1000 IU vitamin A) (Auum Inc., Timmons, On) or 2.5 mL olive oil (Bertolli, Mississauga, Ont) with 500 IU vitamin D and 1000 IU vitamin A added twice daily with breakfast and dinner.
All supplementation amounts are within the amounts specified by Health Canada Guidelines.
Session 2 - After the 21 day supplementation period, participants will return to the lab for a second evaluatory session using identical protocols to session 1.
- Conditions
- Muscle Fatigue, Muscle Strength
- Being tested
- Omega-3, Olive oil
- Keywords
- Randomized clinical trial, Humans, Omega-3 fatty acids, Essential fatty acid, Neuromuscular function, Wingate, Maximum voluntary contraction, Electromyography, Seal oil, Cycling time trial, Placebo controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called Auum Omega Sublingual D, NPN 80014581
Olive oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | Participants will consume 5 mL of omega-3 (2333 mg essential fatty acids) with 1000 IU vitamin D3 for 21 days. Receives: Dietary Supplement: Omega-3 |
| Olive oil | Placebo comparator | Participants will consume 5 mL of olive oil with 1000 IU vitamin D3 for 21 days. Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in maximum voluntary contraction force
Participants will be seated with their right knee fixed at 90°. The right ankle will be restrained by a padded cuff attached in series to a load cell. Participants will be instructed to contract their quadriceps maximally by trying to extending their leg. The load cell will measure the maximum force produced.
Measured: 21 days
Secondary outcomes (11)
Change from baseline in vertical jump height
Participants will perform both squat jumps and counter movement jumps on a force plate. Jump height (cm) will be measured.
Measured: 21 days
Change from baseline in number of push-ups
Participants will perform the maximum number of push-ups possible in one minute while maintaining proper form. A one minute rest will be given and then they will repeat the same procedure.
Measured: 21 days
Change from baseline in number of 10RM squats
Participants will complete as many reps of back squats possible using the 10 repetition maximum weight established during familiarization.
Measured: 21 days
Change from baseline in Wingate test peak power
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight. Peak power, average power, fatigue index and cadence will all be measured.
Measured: 21 days
Change from baseline in 250 kJ cycling time trial time to completion
Participants will complete 250 kJ (kilo Joules) of cycling on an ergometer which is equivalent to 10km. Time to completion and average power (Watts) will be measured.
Measured: Baseline and 21 days
Change from baseline in Pre/Post maximal voluntary contraction force
Pre/Post quadriceps maximal voluntary contraction force is the difference in maximal voluntary contraction force measured at the beginning and end of each testing session to determine changes in neuromuscular function as a result of the other fatiguing tests.
Measured: 21 days
Change from baseline in quadriceps voluntary activation
Participants femoral nerve will be electrically stimulated during the maximal voluntary contraction. Voluntary activation is the difference in muscle force output between the voluntary contraction and the electrically stimulated contraction.
Measured: 21 days
Change from baseline in Wingate test average power
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight. Peak power, average power, fatigue index and cadence will all be measured.
Measured: 21 days
Change from baseline in Wingate test fatigue index
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight. Peak power, average power, fatigue index and cadence will all be measured.
Measured: 21 days
Change from baseline in Wingate test cadence
Participants will perform a 30 second maximal cycling sprint with the resistance set at 7.5% of their baseline body weight. Peak power, average power, fatigue index and cadence will all be measured.
Measured: 21 days
Change from baseline in 250 kJ cycling time trial average power
Participants will complete 250 kJ of cycling on an ergometer which is equivalent to 10km. Time to completion and average power (Watts) will be measured.
Measured: Baseline and 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle FatigueStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Wolever, University of Toronto
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014233
- Sponsor's protocol ID
- UTTW-N3-1
- Status last verified
- May 2016
- First submitted
- 25 Oct 2013
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Millet GY, Tomazin K, Verges S, Vincent C, Bonnefoy R, Boisson RC, Gergele L, Feasson L, Martin V. Neuromuscular consequences of an extreme mountain ultra-marathon. PLoS One. 2011 Feb 22;6(2):e17059. doi: 10.1371/journal.pone.0017059.
PubMed 21364944Presland JD, Dowson MN, Cairns SP. Changes of motor drive, cortical arousal and perceived exertion following prolonged cycling to exhaustion. Eur J Appl Physiol. 2005 Sep;95(1):42-51. doi: 10.1007/s00421-005-1395-3. Epub 2005 Jun 23.
PubMed 15976997Rodacki CL, Rodacki AL, Pereira G, Naliwaiko K, Coelho I, Pequito D, Fernandes LC. Fish-oil supplementation enhances the effects of strength training in elderly women. Am J Clin Nutr. 2012 Feb;95(2):428-36. doi: 10.3945/ajcn.111.021915. Epub 2012 Jan 4.
PubMed 22218156MERTON PA. Voluntary strength and fatigue. J Physiol. 1954 Mar 29;123(3):553-64. doi: 10.1113/jphysiol.1954.sp005070. No abstract available.
PubMed 13152698Behm DG, St-Pierre DM, Perez D. Muscle inactivation: assessment of interpolated twitch technique. J Appl Physiol (1985). 1996 Nov;81(5):2267-73. doi: 10.1152/jappl.1996.81.5.2267.
PubMed 8941554
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short Term Omega-3 Supplementation on Exercise Performance and Neuromuscular Function.
- ClinicalTrials.gov ID
- NCT02014233
- Acronym / sponsor ID
- UTTW-N3-1
- Conditions
- Muscle Fatigue, Muscle Strength
- Keywords
- Randomized clinical trial, Humans, Omega-3 fatty acids, Essential fatty acid, Neuromuscular function, Wingate, Maximum voluntary contraction, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Dec 2013 (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.
Nerves are the rate limiting factor that control muscle function. However, it is unknown if a nutritional supplement can change the nerve-muscle interaction, and therefore alter human performance. This study will be the first to examine the effects of omega-3 supplementation on neuromuscular function in trained individuals.
Detailed description
Participants will come to the lab for 3 sessions, one for familiarization and two for testing.
Familiarization - At this time, anthropometric measurements including height, weight, BMI (body mass index) and body composition will be determined. Participants will be familiarized with the interpolated twitch technique and performing a maximal voluntary contraction of the quadriceps muscle. Next, Participant's 10 repetition maximum squat weight will be established by starting at a participant selected weight and gradually increasing until only 10 squat repetitions can be completed. A VO2max (maximum oxygen consumption) test will be performed on a cycle ergometer using standard methods.
On testing sessions 1 and 2 the following neuromuscular and performance measures will be evaluated:
- Quadriceps muscle voluntary activation will be assessed using the interpolated twitch technique and doublet twitch technique. Participants will be seated and instructed to perform three 5 second maximal voluntary isometric contractions at least 1 minute apart - participant's ankle will be restrained by a padded cuff attached to a load cell. For the second maximal isometric contraction at 3 seconds into the contraction, a square wave superimposed stimulus will be delivered for 1 milliseconds to the femoral nerve from a monopolar touch-proof cathode electrode secured in the femoral triangle. 2, 7 and 12 seconds after the contraction a resting twitch will be delivered for comparison of muscle force. For the third maximal isometric contraction, at 3 seconds into the contraction, two 1 millisecond square wave superimposed stimuli at 100 Hz will be delivered 10 milliseconds apart. 2 seconds after the contraction the same stimulus will be applied. At 7 seconds after, two stimuli will be delivered 100 milliseconds at 10 Hz apart and 12 seconds after a single stimulus will be delivered. The percutaneous electrical stimulation will be delivered from a Biopac stimulator (BSLSTMA, Biopac Systems, Santa Barbara, California) with a maximum voltage of 400 V. During familiarization, participants will receive several submaximal stimulations for acclimatization before the current intensity is gradually increased until peak twitch torque and muscle action potential amplitude is reached. A stimulus of 1.2 times the current required to elicit peak twitch torque and action potential amplitude will be used to ensure maximal activation. The interpolated twitch technique will be used to examine the difference in muscle activation during maximal contraction and a superimposed stimulation. Voluntary activation will be calculated using the formula: Voluntary activation (%) = (1- superimposed twitch / twitch evoked at rest) x 100 Surface self-adhesive silver chloride electrodes will be placed over the belly of the vastus lateralis, vastus medialis and biceps femoris muscles to measure muscle electrical activity (electromyography) during maximal voluntary contractions as previously described.
- Vertical jump - Quadriceps power will be assessed using the vertical jump test on a force plate (AMTI, Watertown, Massachusetts, USA). Participants will complete two attempts to jump as high as possible from crouched and two attempts using the counter jump technique (participants can start from standing, bend the knees and then jump).
- Push-up - Upper body strength endurance will be examined by having the participant complete as many push-ups as possible in one-minute. Participants will be given one-minute rest before being asked to complete as many push-ups as possible in a minute. A piece of soft foam will be attached to the floor to provide participants feedback as to how low the must go when performing each push-up.
- 10RM (10 repetition maximum) squat - After completing an optional 2 to 4 repetitions of 75% of the their 10RM weight as determined during baseline data collection, participants will complete as many repetitions as possible.
- Wingate test - Participants will be fitted to a cycle ergometer (Excalibur Sport V2.0, Lode, Groningen, The Netherlands). They will then cycle against a fixed resistance of 0.075kg / kg body mass for 30 seconds using their maximum effort. Verbal encouragement will be provided to the participant to help produce their maximum effort.
- Cycling time trial - Participants will complete a 10km time trial on a cycle ergometer (Excalibur Sport V2.0, Lode, Groningen, The Netherlands). Participants' inspired and expired gasses will be measured using a metabolic cart (Cortex, Leipzig, Germany). Gas variables and cycling power output will be measured using the supplied software. This change in protocol does not alter the risk to participants as their level of conditioning is quite high and similar levels of exertion would be required in their daily training.
Supplementation - In between sessions 1 and 2, there is a 21 day break for which participants will be computer randomized to either the omega-3 supplementation or an olive oil placebo. Participants will take a 2.5 mL serving of seal oil (2500 mg n-3, 255 mg DHA (docosahexaenoic acid ) and 187.5 mg EPA (eicosapentaenoic acid) with 500 IU vitamin D3 and 1000 IU vitamin A) (Auum Inc., Timmons, On) or 2.5 mL olive oil (Bertolli, Mississauga, Ont) with 500 IU vitamin D and 1000 IU vitamin A added twice daily with breakfast and dinner.
All supplementation amounts are within the amounts specified by Health Canada Guidelines.
Session 2 - After the 21 day supplementation period, participants will return to the lab for a second evaluatory session using identical protocols to session 1.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3Participants will consume 5 mL of omega-3 (2333 mg essential fatty acids) with 1000 IU vitamin D3 for 21 days. |
| Olive oil | Placebo comparator | Dietary Supplement: Olive oilParticipants will consume 5 mL of olive oil with 1000 IU vitamin D3 for 21 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least 2 years training experience that includes resistance training, specifically back squat
- Successfully completing a Par-Q questionnaire
Key exclusion criteria (3 listed)
- Individuals that have or are currently taking an omega-3 and/or omega-6 supplement within 4 weeks of the study
- Individuals that have taken mammalian based omega-3 or 6 supplements in the past 6 months
- Individuals consuming fish more than twice per week within 4 weeks of the study
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 |
|---|---|---|
| Omega-3Also: Auum Omega Sublingual D, NPN 80014581 | Dietary supplement | Omega-3 |
| Olive oil | Dietary supplement | Olive oil |
Primary outcome
Change from baseline in maximum voluntary contraction force
Time frame: 21 days
Participants will be seated with their right knee fixed at 90°. The right ankle will be restrained by a padded cuff attached in series to a load cell. Participants will be instructed to contract their quadriceps maximally by trying to extending their leg. The load cell will measure the maximum force produced.
11 secondary outcomes
Change from baseline in vertical jump height
Time frame: 21 days
Change from baseline in number of push-ups
Time frame: 21 days
Change from baseline in number of 10RM squats
Time frame: 21 days
Change from baseline in Wingate test peak power
Time frame: 21 days
Change from baseline in 250 kJ cycling time trial time to completion
Time frame: Baseline and 21 days
Change from baseline in Pre/Post maximal voluntary contraction force
Time frame: 21 days
Change from baseline in quadriceps voluntary activation
Time frame: 21 days
Change from baseline in Wingate test average power
Time frame: 21 days
Change from baseline in Wingate test fatigue index
Time frame: 21 days
Change from baseline in Wingate test cadence
Time frame: 21 days
Change from baseline in 250 kJ cycling time trial average power
Time frame: Baseline and 21 days
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 20 May 2016.
- Background: PubMed 21364944Millet GY, Tomazin K, Verges S, Vincent C, Bonnefoy R, Boisson RC, Gergele L, Feasson L, Martin V. Neuromuscular consequences of an extreme mountain ultra-marathon. PLoS One. 2011 Feb 22;6(2):e17059. doi: 10.1371/journal.pone.0017059.
- Background: PubMed 15976997Presland JD, Dowson MN, Cairns SP. Changes of motor drive, cortical arousal and perceived exertion following prolonged cycling to exhaustion. Eur J Appl Physiol. 2005 Sep;95(1):42-51. doi: 10.1007/s00421-005-1395-3. Epub 2005 Jun 23.
- Background: PubMed 22218156Rodacki CL, Rodacki AL, Pereira G, Naliwaiko K, Coelho I, Pequito D, Fernandes LC. Fish-oil supplementation enhances the effects of strength training in elderly women. Am J Clin Nutr. 2012 Feb;95(2):428-36. doi: 10.3945/ajcn.111.021915. Epub 2012 Jan 4.
- Background: PubMed 13152698MERTON PA. Voluntary strength and fatigue. J Physiol. 1954 Mar 29;123(3):553-64. doi: 10.1113/jphysiol.1954.sp005070. No abstract available.
- Background: PubMed 8941554Behm DG, St-Pierre DM, Perez D. Muscle inactivation: assessment of interpolated twitch technique. J Appl Physiol (1985). 1996 Nov;81(5):2267-73. doi: 10.1152/jappl.1996.81.5.2267.
- Individual participant dataSharing planned: No
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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.
Thomas MS Wolever, MD, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and Olive oil in people with Muscle Fatigue and Muscle Strength, run by University of Toronto at 1 site in Canada.
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 2 inclusion and 3 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 20 May 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 Canada. 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. Some participants in this study may receive a placebo. 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 from baseline in maximum voluntary contraction force (time frame: 21 days). 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 NCT02014233, which also lists 5 linked publications.
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 20 May 2016.