Body Composition, BeneficialNCT02571322
Whole Body Vibration Training on Body Composition
A study testing HyperVibe Whole Body Vibration training device and Aerobic Exercise in people with Body Composition, Beneficial and Physical Fitness, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Beneficial, Physical Fitness
- What is being tested?
- HyperVibe Whole Body Vibration training device and Aerobic Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2016to 12 Jan 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 18 to 65 years old
- Interest in participating in a study to investigate the effects of a novel exercise training style
- Willing to follow recommendations for participating in the study
- Able to provide informed consent to participate in the study
Who cannot join
- Women who are pregnant or attempting pregnancy during the next 24 weeks
- Anyone with a cardiovascular, orthopedic, or other physical condition that would be contraindicated for an exercise training program
- Any condition where WBV is contraindicated, e.g., seizure disorder
- Currently enrolled in another exercise intervention research study
- Currently undergoing internal defibrillation, like with an implantable heart device
- Erratic, accelerated, or mechanically controlled irregular heart rhythms
Show all 10Show fewer
- Atrial fibrillation/flutter
- Atrioventricular block
- Recently had dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein
- Any implanted electronic device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences
Miami, Florida, 33136
About this study
Official title: The Effect of Whole Body Vibration Training on Body Composition, Physical Fitness, and Quality of Life
The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.
Read the detailed description
The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.Twenty healthy adult males and females (ages 18-65) with no contraindications for exercise training will be recruited to participate in the study. Subjects will participate in a randomized, crossover trial for 24 weeks. Subjects will be assigned to either: (1) WBV for the first 12 weeks and then aerobic exercise training for the second 12 weeks 3 times per week (n=10) or (2) aerobic exercise training for the first 12 weeks and then WBV for the second 12 weeks 3 times per week (n=10). Subjects will be assessed at baseline and at 12 and 24 weeks on aerobic capacity (estimated VO2max), upper and lower body strength (1-repetition maximum on bench press and leg press, respectively), compartmental and total body fat mass, fat free mass, and bone mineral density (using dual energy x-ray absorptiometry (DEXA)), body mass index (height relative to weight), weight, skin fold and body part circumferences, resting blood pressure and pulse, and subjective health-related quality of life (SF-36). Participants will be trained and assessed at the University of Miami Miller School of Medicine UHealth Fitness and Wellness Center, in UHealth Champions Executive Medicine, and in the Department of Psychiatry and Behavioral Sciences.
No substantial psychological, medical, or social risks exist to the participants. Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the Institutional Review Board (IRB).
Exercise has been shown to be safe among every population, including those with chronic diseases and/or other complications. A DEXA scan is the equivalent of about 4 extra days' worth of naturally-occurring radiation.
The use of the HyperVibe WBV training device should be harmless without any known negative effects, as WBV is even lower risk than aerobic exercise, as the participant simply stands on the platform without moving while being exposed to full-body vibration. The system is completely non-invasive, and no serious, untoward side effects have been reported to the manufacturer (HyperVibe) of this system. All study personnel will follow instructions for operating the system. Participants will incur no additional appreciable psychological or social risks by participating in this study.
The results obtained in this study may demonstrate a way to increase exercise efficiency through the use of WBV in helping overweight/obese participants to lose weight, gain muscular weight, and improve physical fitness levels. By participating in the study, subjects may improve their overall health status in a unique approach to exercise training. The minimal risk of participating in this study is reasonable because the potential information gained can be worthwhile for helping people to lose weight, which is significant, given the inordinate prevalence of overweight/obesity and its co morbid chronic diseases in the United States today.
- Conditions
- Body Composition, Beneficial, Physical Fitness
- Being tested
- HyperVibe Whole Body Vibration training device, Aerobic Exercise
- Medical subject headings
- Glucocorticoid Receptor Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperVibe Whole Body Vibration training deviceDevice
Standing on the HyperVibe platform during WBV training will cause repetitive upward movements of platform to be felt by participant.Thus the participant will feel a whole body vibration, as the name of training implies. Each session will last approximately fifteen minutes.
Aerobic ExerciseOther
Aerobic exercise session will last approximately thirty minutes. Starting training intensity will be specific to each participant based on his/her baseline fitness level.
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration training | Experimental | Use of the HyperVibe Whole Body Vibration training device for 12 weeks 3 times per week crossover to aerobic exercise Receives: Device: HyperVibe Whole Body Vibration training device |
| Aerobic Exercise | Placebo comparator | Aerobic exercise training for 12 weeks 3 times per week crossover to use of the HyperVibe Whole Body Vibration training device Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body composition
Body composition will be evaluated by DEXA scan which measure fat free mass , total body and compartmental fat mass
Measured: Baseline,12 weeks and 24 weeks
Change from baseline in aerobic capacity
Aerobic capacity and strength will be assessed by Graded Exercise Test
Measured: Baseline,12 weeks and 24 weeks
Change from baseline in body strength
Overall upper and lower body strength will be assessed by one-repetition maximum strength tests
Measured: Baseline,12 weeks and 24 weeks
Change from baseline in bone mineral density
Bone mineral density will be assessed by DEXA scan
Measured: Baseline,12 weeks and 24 weeks
Secondary outcomes (4)
Change from baseline in physical activity
Physical activity will be assessed with International Physical Activity Questionnaire (IPAQ). The IPAQ items are structured to provide individual domain specific scores for walking, moderate-intensity, and vigorous activity within the domains of work, transportation, domestic chores and gardening, and leisure-time. The tool asks about the time spent doing a specific physical activity in the last 7 days. For total scores, the duration (in minutes) and frequency for all types of activities in all domains are summed, while specific domain scores are calculated by the summation of the walking, moderate-intensity and vigorous-intensity activities within the specific domain. For activity-specific scores, the scores for the specific type of activity across domains are added. To measure the volume of activity, each type of activity is weighted by its energy requirement defined as the metabolic equivalent of task-minute (MET-min).
Measured: Baseline,12 weeks and 24 weeks
Change from baseline in quality of life
The SF-36 (v2) Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure that does not target a specific age, disease, or treatment group.
Measured: Baseline,12 weeks and 24 weeks
Change from baseline in systolic blood pressure
Systolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis
Measured: Baseline,12 weeks and 24 weeks
Change from baseline in diastolic blood pressure
Diastolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis
Measured: Baseline,12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start19 Jan 2016
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
Why it stopped: Lack of funding; logistics of conducting study were very complex.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Body Composition, BeneficialStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- HyperVibe Pty Ltd
- Responsible party
- Principal investigator, John E. Lewis, University of Miami
- Investigators
- John E Lewis, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571322
- Sponsor's protocol ID
- 20150524
- Status last verified
- Mar 2017
- First submitted
- 28 Sep 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Adcox, S (2002, September 21). New state law seeks to cut down obesity. Ithaca Journal.
Baumgartner RN, Roche AF, Guo S, Lohman T, Boileau RA, Slaughter MH. Adipose tissue distribution: the stability of principal components by sex, ethnicity and maturation stage. Hum Biol. 1986 Oct;58(5):719-35. No abstract available.
PubMed 3804294Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.
PubMed 16372905Bosco C, Colli R, Introini E, Cardinale M, Tsarpela O, Madella A, Tihanyi J, Viru A. Adaptive responses of human skeletal muscle to vibration exposure. Clin Physiol. 1999 Mar;19(2):183-7. doi: 10.1046/j.1365-2281.1999.00155.x.
PubMed 10200901Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
PubMed 15706558Centers for Disease Control and Prevention. (2014). National diabetes statistics report Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.
PubMed 17601464Church TS, Kampert JB, Gibbons LW, Barlow CE, Blair SN. Usefulness of cardiorespiratory fitness as a predictor of all-cause and cardiovascular disease mortality in men with systemic hypertension. Am J Cardiol. 2001 Sep 15;88(6):651-6. doi: 10.1016/s0002-9149(01)01808-2.
PubMed 11564389Cochrane DJ, Stannard SR, Sargeant AJ, Rittweger J. The rate of muscle temperature increase during acute whole-body vibration exercise. Eur J Appl Physiol. 2008 Jul;103(4):441-8. doi: 10.1007/s00421-008-0736-4.
PubMed 18392845Colditz GA. Economic costs of obesity and inactivity. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S663-7. doi: 10.1097/00005768-199911001-00026.
PubMed 10593542Cormie P, Deane RS, Triplett NT, McBride JM. Acute effects of whole-body vibration on muscle activity, strength, and power. J Strength Cond Res. 2006 May;20(2):257-61. doi: 10.1519/R-17835.1.
PubMed 16686550Da Silva ME, Fernandez JM, Castillo E, Nunez VM, Vaamonde DM, Poblador MS, Lancho JL. Influence of vibration training on energy expenditure in active men. J Strength Cond Res. 2007 May;21(2):470-5. doi: 10.1519/R-19025.1.
PubMed 17530948Dastmenash, S., van den Tillaar, R., Jacobs, P., Shafiee, G., & Shojaedin, S. (2010). The effect of whole body vibration, PNF training or a combination of both on hamstrings range of motion. World Applied Sciences Journal, 11, 744-751
Di Pietro L, Dziura J, Blair SN. Estimated change in physical activity level (PAL) and prediction of 5-year weight change in men: the Aerobics Center Longitudinal Study. Int J Obes Relat Metab Disord. 2004 Dec;28(12):1541-7. doi: 10.1038/sj.ijo.0802821.
PubMed 15543159Ditschuneit HH, Flechtner-Mors M. Value of structured meals for weight management: risk factors and long-term weight maintenance. Obes Res. 2001 Nov;9 Suppl 4:284S-289S. doi: 10.1038/oby.2001.132.
PubMed 11707555
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration Training on Body Composition, Physical Fitness, and Quality of Life
- ClinicalTrials.gov ID
- NCT02571322
- Acronym / sponsor ID
- 20150524
- Conditions
- Body Composition, Beneficial, Physical Fitness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding; logistics of conducting study were very complex.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- HyperVibe Pty Ltd
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 8 Oct 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.
The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.
Detailed description
The purpose of the study is to determine the effect of whole-body vibration (WBV) on body composition, physical fitness, and quality of life.Twenty healthy adult males and females (ages 18-65) with no contraindications for exercise training will be recruited to participate in the study. Subjects will participate in a randomized, crossover trial for 24 weeks. Subjects will be assigned to either: (1) WBV for the first 12 weeks and then aerobic exercise training for the second 12 weeks 3 times per week (n=10) or (2) aerobic exercise training for the first 12 weeks and then WBV for the second 12 weeks 3 times per week (n=10). Subjects will be assessed at baseline and at 12 and 24 weeks on aerobic capacity (estimated VO2max), upper and lower body strength (1-repetition maximum on bench press and leg press, respectively), compartmental and total body fat mass, fat free mass, and bone mineral density (using dual energy x-ray absorptiometry (DEXA)), body mass index (height relative to weight), weight, skin fold and body part circumferences, resting blood pressure and pulse, and subjective health-related quality of life (SF-36). Participants will be trained and assessed at the University of Miami Miller School of Medicine UHealth Fitness and Wellness Center, in UHealth Champions Executive Medicine, and in the Department of Psychiatry and Behavioral Sciences.
No substantial psychological, medical, or social risks exist to the participants. Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the Institutional Review Board (IRB).
Exercise has been shown to be safe among every population, including those with chronic diseases and/or other complications. A DEXA scan is the equivalent of about 4 extra days' worth of naturally-occurring radiation.
The use of the HyperVibe WBV training device should be harmless without any known negative effects, as WBV is even lower risk than aerobic exercise, as the participant simply stands on the platform without moving while being exposed to full-body vibration. The system is completely non-invasive, and no serious, untoward side effects have been reported to the manufacturer (HyperVibe) of this system. All study personnel will follow instructions for operating the system. Participants will incur no additional appreciable psychological or social risks by participating in this study.
The results obtained in this study may demonstrate a way to increase exercise efficiency through the use of WBV in helping overweight/obese participants to lose weight, gain muscular weight, and improve physical fitness levels. By participating in the study, subjects may improve their overall health status in a unique approach to exercise training. The minimal risk of participating in this study is reasonable because the potential information gained can be worthwhile for helping people to lose weight, which is significant, given the inordinate prevalence of overweight/obesity and its co morbid chronic diseases in the United States today.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration training | Experimental | Device: HyperVibe Whole Body Vibration training deviceUse of the HyperVibe Whole Body Vibration training device for 12 weeks 3 times per week crossover to aerobic exercise |
| Aerobic Exercise | Placebo comparator | Other: Aerobic ExerciseAerobic exercise training for 12 weeks 3 times per week crossover to use of the HyperVibe Whole Body Vibration training device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women ages 18 to 65 years old
- Interest in participating in a study to investigate the effects of a novel exercise training style
- Willing to follow recommendations for participating in the study
- Able to provide informed consent to participate in the study
Key exclusion criteria (10 listed)
- Women who are pregnant or attempting pregnancy during the next 24 weeks
- Anyone with a cardiovascular, orthopedic, or other physical condition that would be contraindicated for an exercise training program
- Any condition where WBV is contraindicated, e.g., seizure disorder
- Currently enrolled in another exercise intervention research study
- Currently undergoing internal defibrillation, like with an implantable heart device
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 |
|---|---|---|
| HyperVibe Whole Body Vibration training deviceStanding on the HyperVibe platform during WBV training will cause repetitive upward movements of platform to be felt by participant.Thus the participant will feel a whole body vibration, as the name of training implies. Each session will last approximately fifteen minutes. | Device | Whole Body Vibration training |
| Aerobic ExerciseAerobic exercise session will last approximately thirty minutes. Starting training intensity will be specific to each participant based on his/her baseline fitness level. | Other | Aerobic Exercise |
Primary outcome
Change from baseline in body composition
Time frame: Baseline,12 weeks and 24 weeks
Body composition will be evaluated by DEXA scan which measure fat free mass , total body and compartmental fat mass
Change from baseline in aerobic capacity
Time frame: Baseline,12 weeks and 24 weeks
Aerobic capacity and strength will be assessed by Graded Exercise Test
Change from baseline in body strength
Time frame: Baseline,12 weeks and 24 weeks
Overall upper and lower body strength will be assessed by one-repetition maximum strength tests
Change from baseline in bone mineral density
Time frame: Baseline,12 weeks and 24 weeks
Bone mineral density will be assessed by DEXA scan
4 secondary outcomes
Change from baseline in physical activity
Time frame: Baseline,12 weeks and 24 weeks
Change from baseline in quality of life
Time frame: Baseline,12 weeks and 24 weeks
Change from baseline in systolic blood pressure
Time frame: Baseline,12 weeks and 24 weeks
Change from baseline in diastolic blood pressure
Time frame: Baseline,12 weeks and 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- BackgroundAdcox, S (2002, September 21). New state law seeks to cut down obesity. Ithaca Journal.
- Background: PubMed 3804294Baumgartner RN, Roche AF, Guo S, Lohman T, Boileau RA, Slaughter MH. Adipose tissue distribution: the stability of principal components by sex, ethnicity and maturation stage. Hum Biol. 1986 Oct;58(5):719-35. No abstract available.
- Background: PubMed 16372905Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of Whole Body Vibration in institutionalised elderly persons and its influence on muscle performance, balance and mobility: a randomised controlled trial [ISRCTN62535013]. BMC Geriatr. 2005 Dec 22;5:17. doi: 10.1186/1471-2318-5-17.
- Background: PubMed 10200901Bosco C, Colli R, Introini E, Cardinale M, Tsarpela O, Madella A, Tihanyi J, Viru A. Adaptive responses of human skeletal muscle to vibration exposure. Clin Physiol. 1999 Mar;19(2):183-7. doi: 10.1046/j.1365-2281.1999.00155.x.
- Background: PubMed 15706558Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
- BackgroundCenters for Disease Control and Prevention. (2014). National diabetes statistics report Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
- Background: PubMed 17601464Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.
- Background: PubMed 11564389Church TS, Kampert JB, Gibbons LW, Barlow CE, Blair SN. Usefulness of cardiorespiratory fitness as a predictor of all-cause and cardiovascular disease mortality in men with systemic hypertension. Am J Cardiol. 2001 Sep 15;88(6):651-6. doi: 10.1016/s0002-9149(01)01808-2.
- Background: PubMed 18392845Cochrane DJ, Stannard SR, Sargeant AJ, Rittweger J. The rate of muscle temperature increase during acute whole-body vibration exercise. Eur J Appl Physiol. 2008 Jul;103(4):441-8. doi: 10.1007/s00421-008-0736-4.
- Background: PubMed 10593542Colditz GA. Economic costs of obesity and inactivity. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S663-7. doi: 10.1097/00005768-199911001-00026.
- Background: PubMed 16686550Cormie P, Deane RS, Triplett NT, McBride JM. Acute effects of whole-body vibration on muscle activity, strength, and power. J Strength Cond Res. 2006 May;20(2):257-61. doi: 10.1519/R-17835.1.
- Background: PubMed 17530948Da Silva ME, Fernandez JM, Castillo E, Nunez VM, Vaamonde DM, Poblador MS, Lancho JL. Influence of vibration training on energy expenditure in active men. J Strength Cond Res. 2007 May;21(2):470-5. doi: 10.1519/R-19025.1.
- 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.
John E Lewis, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyperVibe Whole Body Vibration training device and Aerobic Exercise in people with Body Composition, Beneficial and Physical Fitness, run by University of Miami at 1 site in United States.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 3 Mar 2017. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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 body composition (time frame: Baseline,12 weeks and 24 weeks). The study lists 4 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 NCT02571322, which also lists 47 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 3 Mar 2017.