Training Group, SensitivityNCT03477747
The Application of Microcurrent in Athletes
A study testing Microcurrent in people with Training Group, Sensitivity, run by University of Greenwich at 1 site in United Kingdom.
Trial summary
The aim of this investigation is to analyse the potential benefits of wearing a new commercially available microcurrent device combined with different exercise training modalities on exercise outcomes, body composition, recovery including muscle damage, general markers of health and immune function in athletes. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Training Group, Sensitivity
- What is being tested?
- Microcurrent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2018to 31 Dec 2018
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regularly trained endurance or strength athletes
- Minimum of 6 months of experience
Who cannot join
- Musculoskeletal injuries, metabolic diseases
- Use of medications
- Smoking
- Consuming any nutritional supplements that potentially affect physical performance (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Life and Sports Science
Eltham, London, SE9 2BT
About this study
Official title: Efficacy of Microcurrent to Maximise Exercise Outcomes, Accelerate Recovery and Attenuate Muscle Damage in Athletes
The aim of this investigation is to analyse the potential benefits of wearing a new commercially available microcurrent device combined with different exercise training modalities on exercise outcomes, body composition, recovery including muscle damage, general markers of health and immune function in athletes.
Read the detailed description
The investigation involves two randomised, balanced, double-blind parallel group between-participants design, aimed to analyse the effects of combining microcurrent with resistance and endurance training. Participants, once considered eligible for the study will be familiarised with the respective exercises, as well as tested for baseline values. Thereafter participants will be randomly assigned to one of the following intervention groups (1) Microcurrent (MCR+RT) with resistance training (2) Microcurrent (MCR+END) with endurance training (3) Sham with resistance training (SH+RT) and (4) Sham with endurance training (SH+END). Participants will perform 3 supervised training sessions per week (24 total workouts). Participants will wear the microcurrent or sham devices during 3 hr after workouts. Each group will follow a 10-week resistance or endurance training intervention combined with one of the two specific treatments (MCR or SH). Measurements of body composition, muscle thickness, performance, salivary and blood markers as well as delayed onset of muscle soreness will be determined before and after each particular (resistance or endurance training) intervention.
Participants It is anticipated that sixty participants, recruited from the Medway University Campus, will take part in the project. Inclusion criteria are: regularly trained male or female athletes, aged 18 to 45 years old, with at least 3 months of experience in resistance or endurance training, with no musculoskeletal injuries, metabolic conditions, or diseases or use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery processes (e.g., creatine, whey protein, and amino acids, vitamin or mineral supplementation, etc) within 6 weeks prior to the start of the study.
After being informed of all risks and potential benefits involved, participants will sign a written informed participation consent form. Procedures will be in accordance with the Helsinki Declaration and will be approved by the Research Ethics Committee of the University of Greenwich.
Intervention Resistance training groups
Familiarization period:
Participants will undertake 3 sessions of familiarization (1 week). To ensure a correct execution of the selected exercise a qualified strength and conditioning coach will control and assists participants. All participants will be instructed about the appropriate use of the Rate of Perceived Exertion OMNI-RES (0-10) scale to control the load and training intensity during each workout.
The resistance-training program is designed to increase strength and muscle mass of all major muscle groups. Under the supervision of strength and conditioning coaches, preferable a MSc Strength and Conditioning student from the University of Greenwich. The program will be undertaken on three non-consecutive days per week, Training workout will be performed during the afternoon (between 3 pm and 6 pm) with at least 48 hours between sessions.
The intervention period consists of a 8-week periodised resistance training programme divided into 3 blocks: First block (week 1 to week 3) using a moderate load intensity of around 70% 1RM; Second block (week 4 to week 6) where the intensity increases to >75% to 80% 1RM and the third block (week 7 to week 8) where the highest loads (>80 to 85% 1RM) are implemented. The Rate of Perceive Exertion OMNI-RES (0-10) scale (RPE) will be used to appropriately select the loading zone for each particular exercise during the workouts (Naclerio et al., 2015a, Naclerio et al., 2011)
Each workout session begins with individualized warm-up (5-minute warm-up stretches, followed by one set of eight repetitions of six resistance training exercises without any additional weight). Workouts will involve 3 sets of 8 to 10 RM (self maximal estimation) with approximately 2 min of rest of the following exercises:
- Parallel back squat
- Hang clean
- Alternate lunges with dumbbells
- Bench press
- Upright row
- Double leg dead lift
- Push Press
- Front shoulder press and
- Biceps curl.
Each workout will last between 45 to 60 min.
The load will be increased or decrease based on the self-perception of the participants. When a minimum of 8 Reps is no possible to complete the participants will rest for 15sec and complete the set. Additionally, the participants can decide to reduce the load for the next set. Conversely, when more than 10 reps can be performed, the participants will stop the set, increase the load and complete the 10RM set.
Endurance training Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity [≥ the first ventilatory threshold (VT1), ~ 70% HRmax]; moderate intensity [between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), >70 < 90% HRmax]; and high intensity [>VT2, 90% HRmax] (Esteve-Lanao et al., 2007). Participants will train 4 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Participants have to be completed the same time exposure to the MCR or SH device after the end of the intervention period.
Microcurrent or shadow
Both the microcurrent and sham devices will look exactly the same in terms of appearance, colour, size and weight. As the current transmitted from the microcurrent device is insufficient to stimulate sensory nerve fibres, this stimulus is imperceptible and together with the same appearance, participants nor strength and conditioning coaches or researchers involved in testing will be able to identify participants under the MCR or the SH treatment. Only one researcher not involved in the assessment and training supervision will know the participant allocation during the study.
Microcurrent or sham devices will be codified and placed on the participants before each training session. The participants will remove the device 10 to 15 min after completing each training session and return it to the strength and conditioning coach.
- Conditions
- Training Group, Sensitivity
- Being tested
- Microcurrent
- Keywords
- Microcurrent, Exercise training, Hypertrophy, Muscle damage, Recovery, Performance
- Medical subject headings
- Hypersensitivity, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocurrentDevice
Microcurrent based treatments have been proposed more than 30 years. The manufacturer initially should calibrate the microcurrent devices. There is no physical sensation associated with microcurrent based treatments as the strength of the current is not high enough to stimulate sensory nerve fibres. The application of electric fields and currents similar to those generated within the body can substantially change the cell structure and the metabolic behaviour of cells. For example, the application of microcurrent increases the number of organelles responsible for cellular activities; it increases concentrations of adenosine triphosphate (ATP) and amino acid transport; promotes protein synthesis; fastens regrowth of atrophied soleus muscle and would also activate hormone-sensitive lipase which can increase lipolysis from the internal and external adipose tissue. The microcurrent treatment with training would maximize exercise and recovery outcomes in athletes.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Microcurrent | Experimental | Participants will combine a 10-week periodized and controlled resistance programme with 3 h of microcurrent after training.
Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness Receives: Device: Microcurrent |
| Resistance Training Shadow | Sham comparator | Participants will combine a 10-week periodized and controlled resistance programme with 3 h of sham comparator after training.
Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness Receives: Device: Microcurrent |
| Endurance Training Microcurrent | Experimental | Participants will combine a 10-week periodized and controlled endurance programme with 3 h of microcurrent after training.
Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness Receives: Device: Microcurrent |
| Endurance Training Shadow | Sham comparator | Participants will combine a 10-week periodized and controlled endurance programme with 3 h of microcurrent after training.
Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness Receives: Device: Microcurrent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Fat mass
Measured: 10 weeks
Body composition
Fat Free Mass
Measured: 10 weeks
Endurance Performance
Vo2 max
Measured: 10 weeks
Strength Performance
Maximal strength
Measured: 10 weeks
Blood Markers
haemoglobin
Measured: 10 weeks
Blood Markers
haematocrit
Measured: 10 weeks
Salivary markers
Cortisol
Measured: 10 weeks
Salivary Markers
HNP1-3
Measured: 10 weeks
Secondary outcomes (4)
Hypertrophy
Muscle Thickness
Measured: 10 weeks
Muscle Damage
Interleukin 1
Measured: 10 weeks
Muscle Damage
Interleukin 6
Measured: 10 weeks
Muscle Damage
Myoglobin
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start2 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Training Group, SensitivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomise controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Greenwich
- Sponsor type
- University, hospital or other
- Collaborators
- Arc Family
- Responsible party
- Principal investigator, Fernando Naclerio, University of Greenwich
- Investigators
- Fernando Naclerio, Ph D, Principal investigator, University of Greenwich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477747
- Sponsor's protocol ID
- UREC/16.3.5.13
- Status last verified
- Apr 2019
- First submitted
- 18 Mar 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microcurrent to Maximise Exercise Outcomes, Accelerate Recovery and Attenuate Muscle Damage in Athletes
- ClinicalTrials.gov ID
- NCT03477747
- Acronym / sponsor ID
- UREC/16.3.5.13
- Conditions
- Training Group, Sensitivity
- Keywords
- Microcurrent, Exercise training, Hypertrophy, Muscle damage, Recovery, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GreenwichUniversity, hospital or other
- Collaborators
- Arc Family
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- 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.
The aim of this investigation is to analyse the potential benefits of wearing a new commercially available microcurrent device combined with different exercise training modalities on exercise outcomes, body composition, recovery including muscle damage, general markers of health and immune function in athletes.
Detailed description
The investigation involves two randomised, balanced, double-blind parallel group between-participants design, aimed to analyse the effects of combining microcurrent with resistance and endurance training. Participants, once considered eligible for the study will be familiarised with the respective exercises, as well as tested for baseline values. Thereafter participants will be randomly assigned to one of the following intervention groups (1) Microcurrent (MCR+RT) with resistance training (2) Microcurrent (MCR+END) with endurance training (3) Sham with resistance training (SH+RT) and (4) Sham with endurance training (SH+END). Participants will perform 3 supervised training sessions per week (24 total workouts). Participants will wear the microcurrent or sham devices during 3 hr after workouts. Each group will follow a 10-week resistance or endurance training intervention combined with one of the two specific treatments (MCR or SH). Measurements of body composition, muscle thickness, performance, salivary and blood markers as well as delayed onset of muscle soreness will be determined before and after each particular (resistance or endurance training) intervention.
Participants It is anticipated that sixty participants, recruited from the Medway University Campus, will take part in the project. Inclusion criteria are: regularly trained male or female athletes, aged 18 to 45 years old, with at least 3 months of experience in resistance or endurance training, with no musculoskeletal injuries, metabolic conditions, or diseases or use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery processes (e.g., creatine, whey protein, and amino acids, vitamin or mineral supplementation, etc) within 6 weeks prior to the start of the study.
After being informed of all risks and potential benefits involved, participants will sign a written informed participation consent form. Procedures will be in accordance with the Helsinki Declaration and will be approved by the Research Ethics Committee of the University of Greenwich.
Intervention Resistance training groups
Familiarization period:
Participants will undertake 3 sessions of familiarization (1 week). To ensure a correct execution of the selected exercise a qualified strength and conditioning coach will control and assists participants. All participants will be instructed about the appropriate use of the Rate of Perceived Exertion OMNI-RES (0-10) scale to control the load and training intensity during each workout.
The resistance-training program is designed to increase strength and muscle mass of all major muscle groups. Under the supervision of strength and conditioning coaches, preferable a MSc Strength and Conditioning student from the University of Greenwich. The program will be undertaken on three non-consecutive days per week, Training workout will be performed during the afternoon (between 3 pm and 6 pm) with at least 48 hours between sessions.
The intervention period consists of a 8-week periodised resistance training programme divided into 3 blocks: First block (week 1 to week 3) using a moderate load intensity of around 70% 1RM; Second block (week 4 to week 6) where the intensity increases to >75% to 80% 1RM and the third block (week 7 to week 8) where the highest loads (>80 to 85% 1RM) are implemented. The Rate of Perceive Exertion OMNI-RES (0-10) scale (RPE) will be used to appropriately select the loading zone for each particular exercise during the workouts (Naclerio et al., 2015a, Naclerio et al., 2011)
Each workout session begins with individualized warm-up (5-minute warm-up stretches, followed by one set of eight repetitions of six resistance training exercises without any additional weight). Workouts will involve 3 sets of 8 to 10 RM (self maximal estimation) with approximately 2 min of rest of the following exercises:
- Parallel back squat
- Hang clean
- Alternate lunges with dumbbells
- Bench press
- Upright row
- Double leg dead lift
- Push Press
- Front shoulder press and
- Biceps curl.
Each workout will last between 45 to 60 min.
The load will be increased or decrease based on the self-perception of the participants. When a minimum of 8 Reps is no possible to complete the participants will rest for 15sec and complete the set. Additionally, the participants can decide to reduce the load for the next set. Conversely, when more than 10 reps can be performed, the participants will stop the set, increase the load and complete the 10RM set.
Endurance training Participants will commit to follow a polarised triphasic endurance-training model. This model contains three intensity zones calculated as low intensity [≥ the first ventilatory threshold (VT1), ~ 70% HRmax]; moderate intensity [between VT1 and respiratory compensation point or ventilatory threshold 2 (VT2), >70 < 90% HRmax]; and high intensity [>VT2, 90% HRmax] (Esteve-Lanao et al., 2007). Participants will train 4 to 6 times per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Participants have to be completed the same time exposure to the MCR or SH device after the end of the intervention period.
Microcurrent or shadow
Both the microcurrent and sham devices will look exactly the same in terms of appearance, colour, size and weight. As the current transmitted from the microcurrent device is insufficient to stimulate sensory nerve fibres, this stimulus is imperceptible and together with the same appearance, participants nor strength and conditioning coaches or researchers involved in testing will be able to identify participants under the MCR or the SH treatment. Only one researcher not involved in the assessment and training supervision will know the participant allocation during the study.
Microcurrent or sham devices will be codified and placed on the participants before each training session. The participants will remove the device 10 to 15 min after completing each training session and return it to the strength and conditioning coach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind randomise controlled trial
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Microcurrent | Experimental | Device: MicrocurrentParticipants will combine a 10-week periodized and controlled resistance programme with 3 h of microcurrent after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness |
| Resistance Training Shadow | Sham comparator | Device: MicrocurrentParticipants will combine a 10-week periodized and controlled resistance programme with 3 h of sham comparator after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness |
| Endurance Training Microcurrent | Experimental | Device: MicrocurrentParticipants will combine a 10-week periodized and controlled endurance programme with 3 h of microcurrent after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness |
| Endurance Training Shadow | Sham comparator | Device: MicrocurrentParticipants will combine a 10-week periodized and controlled endurance programme with 3 h of microcurrent after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Regularly trained endurance or strength athletes
- Minimum of 6 months of experience
Key exclusion criteria (4 listed)
- Musculoskeletal injuries, metabolic diseases
- Use of medications
- Smoking
- Consuming any nutritional supplements that potentially affect physical performance (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start 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 |
|---|---|---|
| MicrocurrentMicrocurrent based treatments have been proposed more than 30 years. The manufacturer initially should calibrate the microcurrent devices. There is no physical sensation associated with microcurrent based treatments as the strength of the current is not high enough to stimulate sensory nerve fibres. The application of electric fields and currents similar to those generated within the body can substantially change the cell structure and the metabolic behaviour of cells. For example, the application of microcurrent increases the number of organelles responsible for cellular activities; it increases concentrations of adenosine triphosphate (ATP) and amino acid transport; promotes protein synthesis; fastens regrowth of atrophied soleus muscle and would also activate hormone-sensitive lipase which can increase lipolysis from the internal and external adipose tissue. The microcurrent treatment with training would maximize exercise and recovery outcomes in athletes. | Device | Endurance Training Microcurrent, Endurance Training Shadow, Resistance Training Microcurrent, Resistance Training Shadow |
Primary outcome
Body composition
Time frame: 10 weeks
Fat mass
Body composition
Time frame: 10 weeks
Fat Free Mass
Endurance Performance
Time frame: 10 weeks
Vo2 max
Strength Performance
Time frame: 10 weeks
Maximal strength
Blood Markers
Time frame: 10 weeks
haemoglobin
Blood Markers
Time frame: 10 weeks
haematocrit
Salivary markers
Time frame: 10 weeks
Cortisol
Salivary Markers
Time frame: 10 weeks
HNP1-3
4 secondary outcomes
Hypertrophy
Time frame: 10 weeks
Muscle Damage
Time frame: 10 weeks
Muscle Damage
Time frame: 10 weeks
Muscle Damage
Time frame: 10 weeks
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 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Fernando Naclerio, Ph D principal investigator
University of Greenwich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrent in people with Training Group, Sensitivity, run by University of Greenwich at 1 site in United Kingdom.
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 4 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 17 Apr 2019. 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 United Kingdom. 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?
Body composition (time frame: 10 weeks). The study lists 8 primary outcomes in all. 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 17 Apr 2019.