DisorderNCT03315442
Increased Static Postural Sway After Energy Drink Consumption
A study testing Caffeine versus Energy Drink in people with Disorder, run by Texas Woman's University at 1 site in Puerto Rico.
Trial summary
Background \& Purpose: Energy drinks consumption continues to grow since its appearance in the United States in 1997. Available evidence indicates that caffeine, their main ingredient, can alter the central nervous system (CNS). However, it is unknown how energy drinks adjust the CNS postural control mechanism. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder
- What is being tested?
- Caffeine versus Energy Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 21 Oct 2016to 21 Jul 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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- subjects between 21 to 40 years of age
- functional flexibility in the lower extremities
- functional muscular strength in the lower extremities
- completing the American College Sports Medicine Health/Fitness Facility Pre-participation screening Questionnaire
- Body Mass Index of 18.5 to 29.9
- arterial blood pressure less than or equal to 140/90 mmHg
- pulse at rest between 45-90 beats per minute (BPM) 95% or more of oxygen saturation (spO2).
Who cannot join
- subjects under the age of 21 and over the age of 40
- answering any questions affirmative on the pre-participation questionnaire
- cardiovascular problems
- severe balance problems
- taking any sedative or stimulant medications
- medical history of any neurological condition
Show all 14Show fewer
- a fall in the last three months
- having undergone a surgical procedure in the past six months
- pain in the lower extremities and lower back
- have suffered a lower back injury and in the lower extremities in the last six months
- pregnant or suspecting pregnancy
- experienced adverse effects after caffeine consumption
- caffeine consumption 12 hours before the study intervention
- allergies to one of the energy drink ingredients, and 15) people unable to consent.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Biomechanics Laboratory of the Doctoral Program in Physical Therapy at the School of Health Professions in the Medical Sciences Campus, University of Puerto Rico (UPR-MSC).
San Juan, 00936
About this study
Background \& Purpose: Energy drinks consumption continues to grow since its appearance in the United States in 1997. Available evidence indicates that caffeine, their main ingredient, can alter the central nervous system (CNS). However, it is unknown how energy drinks adjust the CNS postural control mechanism. The purpose of this study was to investigate how energy drinks can affect postural control after sensory perturbations during stance.
Methods: 20 healthy adults, (11 males; 9 females) averaging 26.1 years of age, stood on a pressure mat, which measured center of pressure (CoP), anteroposterior (AP) and mediolateral (ML) postural sways during eight different balance tests (BALT's). BALT's were designed to alter or cancel the systems involved in postural control: visual, vestibular and somatosensory. Subjects were randomly assigned to a caffeine group and an energy drink group. MANOVA analysis was performed for all variables of interest.
Read the detailed description
Methods General Protocol
After signing the informed consent and reviewing the inclusion and exclusion criteria, participants were subjected to a preliminary screening of participation using a list of questions and the American college sports medicine Health / Fitness Facility Questionnaire. This questionnaire's purpose is to ensure the safety of the participants to engage in physical activity by assessing the subjects and family history of cardiovascular diseases. Afterwards, the Investigators assessed subjects' vital signs, blood pressure, pulse, and spO2, to ensure subjects were able to participate in physical activity safely ingest a moderate intake of caffeine without complications. Since postural control is negatively correlated with increased adiposity, weight and height data were measured to obtain a classification according to the Body Mass Index. A range of 18.5 to 29.9 was required to participate. During the physical examinations the subjects also performed a Romberg test to rule out any obvious impairment in static balance, a modified Sit and Reach Test for the evaluation of functional flexibility, Sit to Stand Test (30 Seconds) for the assessment of lower limb functional strength, and a Step Test to evaluate the response of the cardiovascular system to a submaximal cardio test. After the physical examination, the participants had a rest period between 10-20 minutes before starting the balance tests protocol of (BALT's).
Procedure
Each participant from both groups performed eight balance tests (BALT's) which alter or cancel, individually or combined, sensory input from the sensory systems involved in postural control. The order of the tests was changed systematically between subjects; therefore, they did not perform the tests in the same order to eliminate external factors such as fatigue or accommodation to the BALT's, which could alter the results. The BALT's were conducted on the (TekScan, Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose. The subjects stood for 30 seconds on the pressure platform during each test.
The first 4 BALT's were carried out by placing the pressure platform on the floor, a stable surface. These tests were: 1) Open Eyes (EO) with a fixed point to evaluate all the systems involved in the postural control (visual, vestibular, somatosensory); 2) Eyes Closed (EC) to evaluate the vestibular and somatosensory system, while eliminating the visual sensory input; 3) Eyes Open while actively moving the head up and down (HUD) to evaluate the visual and somatosensory system, while altering the vestibular system with head movements (EO HUD) (For HUD movements a metronome 2/4 60 BPM was used to maintain a fixed frequency of about one spin per second in motion); 4) Eyes closed and actively moving the head up and down (EC HUD) to assess the effect of removing the visual input, in combination of an alteration of the vestibular system with the head up and down movements.
The remaining 4 BALT's were the same as the four previously mentioned tests with the difference that the subject stood on an unstable surface (foam mat) that was placed on top of the pressure platform to alter the somatosensory (proprioceptive) system.
After the initial eight pre BALT's, to the experimental group, 160 mg of caffeine was given through one energy drink (16 ounces). Monster energy drink was chosen because, unlike other energy drink brands, the label of Monster Energy drink exhibits the guarana additive, a potential CNS stimulant, in its nutritional label. To the control group, Investigators gave a caffeine pill of 200mg, a moderate dose in healthy adults which has been used in numerous studies on different topics and has not been associated with adverse effects such as toxicity, cardiovascular effects, behavior changes, among other things. Because peak absorption of caffeine is reached within 30-45 minutes after the ingestion of caffeine/energy drink, there was a rest period of 30 minutes. Vital signs were measured after the rest period, for the third time. The same 8 BALT's were then performed, for post ingestion results.
- Conditions
- Disorder
- Being tested
- Caffeine versus Energy Drink
- Keywords
- Fluid, Balance
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine versus Energy DrinkOther
Caffeine group consumed 200mg of caffeine one time, while the energy drink group consumed 1 16 ounces of energy drink.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Group | Sham comparator | Caffeine group consumed 200mg of caffeine one time. Receives: Other: Caffeine versus Energy Drink |
| Energy Drink Group | Experimental | The energy drink group consumed 1 16 ounces energy drink one time. Receives: Other: Caffeine versus Energy Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of Pressure and sway EYES OPEN
Open Eyes (EO) with a fixed point to evaluate all the systems involved in the postural control. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Center of Pressure and sway EYES CLOSED
Eyes Closed (EC) to evaluate the vestibular and somatosensory system, while eliminating the visual sensory input. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Center of Pressure and sway EYES HEAD UP AND DOWN
Eyes Open while actively moving the head up and down (HUD) to evaluate the visual and somatosensory system, while altering the vestibular system with head movements (EO HUD) (For HUD movements a metronome 2/4 60 BPM was used to maintain a fixed frequency of about one spin per second in motion. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Center of Pressure and sway CLOSED HEAD UP AND DOWN
Eyes closed and actively moving the head up and down (EC HUD) to assess the effect of removing the visual input, in a combination of an alteration of the vestibular system with the head up and down movements. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Center of Pressure and sway EYES OPEN ON FOAM
standing on the unstable surface to evaluate the visual and vestibular system while the somatosensory is altered. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Center of Pressure and sway EYES CLOSED ON FOAM
Eyes Closed (MAT EO), standing on the unstable surface to evaluate the vestibular system (the somatosensory was modified and the visual system removed). This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Center of Pressure and sway EYES OPEN HEAD UP AND DOWN
Eyes Open (MAT EO HUD) while actively moving the head up and down to evaluate the visual system, while altering the vestibular and somatosensory system. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Center of Pressure and sway EYES CLOSED HEAD UP AND DOWN
Eyes Closed (MAT EC HUD) while actively moving the head up and down (in this test all three systems were altered). The same frequency of motion used for BALT's 3 and 4 in the stable surface (one spin per second, 60 BPM) was maintained for the BALT's with HUD movements on the unstable surface. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Measured: 30 minutes after caffeine or energy drink consumption
Secondary outcomes (3)
Body Mass Index
kg/m^2
Measured: Pre Balance Test-Assessment
Weight
kilograms
Measured: Pre Balance Test-Assessment
Height
meters
Measured: Pre Balance Test-Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start21 Oct 2016
- Primary completion21 Jan 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisorderStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 healthy adults, (11 males; 9 females) averaging 26.1 years of age, stood on a MatScan™ pressure mat, which measured center of pressure (CoP), anteroposterior (AP) and mediolateral (ML) postural sways during eight different balance tests (BALT's). BALT's were designed to alter or cancel the systems involved in postural control: visual, vestibular and somatosensory. Subjects were randomly assigned to a caffeine group and an energy drink group. MANOVA analysis was performed for all variables of interest.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Rosario, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315442
- Sponsor's protocol ID
- A2540116
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Static Postural Sway After Energy Drink Consumption
- ClinicalTrials.gov ID
- NCT03315442
- Acronym / sponsor ID
- A2540116
- Conditions
- Disorder
- Keywords
- Fluid, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 21 Jan 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 20 Oct 2017 (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.
Background \& Purpose: Energy drinks consumption continues to grow since its appearance in the United States in 1997. Available evidence indicates that caffeine, their main ingredient, can alter the central nervous system (CNS). However, it is unknown how energy drinks adjust the CNS postural control mechanism. The purpose of this study was to investigate how energy drinks can affect postural control after sensory perturbations during stance.
Methods: 20 healthy adults, (11 males; 9 females) averaging 26.1 years of age, stood on a pressure mat, which measured center of pressure (CoP), anteroposterior (AP) and mediolateral (ML) postural sways during eight different balance tests (BALT's). BALT's were designed to alter or cancel the systems involved in postural control: visual, vestibular and somatosensory. Subjects were randomly assigned to a caffeine group and an energy drink group. MANOVA analysis was performed for all variables of interest.
Detailed description
Methods General Protocol
After signing the informed consent and reviewing the inclusion and exclusion criteria, participants were subjected to a preliminary screening of participation using a list of questions and the American college sports medicine Health / Fitness Facility Questionnaire. This questionnaire's purpose is to ensure the safety of the participants to engage in physical activity by assessing the subjects and family history of cardiovascular diseases. Afterwards, the Investigators assessed subjects' vital signs, blood pressure, pulse, and spO2, to ensure subjects were able to participate in physical activity safely ingest a moderate intake of caffeine without complications. Since postural control is negatively correlated with increased adiposity, weight and height data were measured to obtain a classification according to the Body Mass Index. A range of 18.5 to 29.9 was required to participate. During the physical examinations the subjects also performed a Romberg test to rule out any obvious impairment in static balance, a modified Sit and Reach Test for the evaluation of functional flexibility, Sit to Stand Test (30 Seconds) for the assessment of lower limb functional strength, and a Step Test to evaluate the response of the cardiovascular system to a submaximal cardio test. After the physical examination, the participants had a rest period between 10-20 minutes before starting the balance tests protocol of (BALT's).
Procedure
Each participant from both groups performed eight balance tests (BALT's) which alter or cancel, individually or combined, sensory input from the sensory systems involved in postural control. The order of the tests was changed systematically between subjects; therefore, they did not perform the tests in the same order to eliminate external factors such as fatigue or accommodation to the BALT's, which could alter the results. The BALT's were conducted on the (TekScan, Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose. The subjects stood for 30 seconds on the pressure platform during each test.
The first 4 BALT's were carried out by placing the pressure platform on the floor, a stable surface. These tests were: 1) Open Eyes (EO) with a fixed point to evaluate all the systems involved in the postural control (visual, vestibular, somatosensory); 2) Eyes Closed (EC) to evaluate the vestibular and somatosensory system, while eliminating the visual sensory input; 3) Eyes Open while actively moving the head up and down (HUD) to evaluate the visual and somatosensory system, while altering the vestibular system with head movements (EO HUD) (For HUD movements a metronome 2/4 60 BPM was used to maintain a fixed frequency of about one spin per second in motion); 4) Eyes closed and actively moving the head up and down (EC HUD) to assess the effect of removing the visual input, in combination of an alteration of the vestibular system with the head up and down movements.
The remaining 4 BALT's were the same as the four previously mentioned tests with the difference that the subject stood on an unstable surface (foam mat) that was placed on top of the pressure platform to alter the somatosensory (proprioceptive) system.
After the initial eight pre BALT's, to the experimental group, 160 mg of caffeine was given through one energy drink (16 ounces). Monster energy drink was chosen because, unlike other energy drink brands, the label of Monster Energy drink exhibits the guarana additive, a potential CNS stimulant, in its nutritional label. To the control group, Investigators gave a caffeine pill of 200mg, a moderate dose in healthy adults which has been used in numerous studies on different topics and has not been associated with adverse effects such as toxicity, cardiovascular effects, behavior changes, among other things. Because peak absorption of caffeine is reached within 30-45 minutes after the ingestion of caffeine/energy drink, there was a rest period of 30 minutes. Vital signs were measured after the rest period, for the third time. The same 8 BALT's were then performed, for post ingestion results.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 healthy adults, (11 males; 9 females) averaging 26.1 years of age, stood on a MatScan™ pressure mat, which measured center of pressure (CoP), anteroposterior (AP) and mediolateral (ML) postural sways during eight different balance tests (BALT's). BALT's were designed to alter or cancel the systems involved in postural control: visual, vestibular and somatosensory. Subjects were randomly assigned to a caffeine group and an energy drink group. MANOVA analysis was performed for all variables of interest.
| Arm | Type | Receives |
|---|---|---|
| Caffeine Group | Sham comparator | Other: Caffeine versus Energy DrinkCaffeine group consumed 200mg of caffeine one time. |
| Energy Drink Group | Experimental | Other: Caffeine versus Energy DrinkThe energy drink group consumed 1 16 ounces energy drink one time. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- subjects between 21 to 40 years of age
- functional flexibility in the lower extremities
- functional muscular strength in the lower extremities
- completing the American College Sports Medicine Health/Fitness Facility Pre-participation screening Questionnaire
- Body Mass Index of 18.5 to 29.9
Key exclusion criteria (14 listed)
- subjects under the age of 21 and over the age of 40
- answering any questions affirmative on the pre-participation questionnaire
- cardiovascular problems
- severe balance problems
- taking any sedative or stimulant medications
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 |
|---|---|---|
| Caffeine versus Energy DrinkCaffeine group consumed 200mg of caffeine one time, while the energy drink group consumed 1 16 ounces of energy drink. | Other | Caffeine Group, Energy Drink Group |
Primary outcome
Center of Pressure and sway EYES OPEN
Time frame: 30 minutes after caffeine or energy drink consumption
Open Eyes (EO) with a fixed point to evaluate all the systems involved in the postural control. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Center of Pressure and sway EYES CLOSED
Time frame: 30 minutes after caffeine or energy drink consumption
Eyes Closed (EC) to evaluate the vestibular and somatosensory system, while eliminating the visual sensory input. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Center of Pressure and sway EYES HEAD UP AND DOWN
Time frame: 30 minutes after caffeine or energy drink consumption
Eyes Open while actively moving the head up and down (HUD) to evaluate the visual and somatosensory system, while altering the vestibular system with head movements (EO HUD) (For HUD movements a metronome 2/4 60 BPM was used to maintain a fixed frequency of about one spin per second in motion. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Center of Pressure and sway CLOSED HEAD UP AND DOWN
Time frame: 30 minutes after caffeine or energy drink consumption
Eyes closed and actively moving the head up and down (EC HUD) to assess the effect of removing the visual input, in a combination of an alteration of the vestibular system with the head up and down movements. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Center of Pressure and sway EYES OPEN ON FOAM
Time frame: 30 minutes after caffeine or energy drink consumption
standing on the unstable surface to evaluate the visual and vestibular system while the somatosensory is altered. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Center of Pressure and sway EYES CLOSED ON FOAM
Time frame: 30 minutes after caffeine or energy drink consumption
Eyes Closed (MAT EO), standing on the unstable surface to evaluate the vestibular system (the somatosensory was modified and the visual system removed). This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Center of Pressure and sway EYES OPEN HEAD UP AND DOWN
Time frame: 30 minutes after caffeine or energy drink consumption
Eyes Open (MAT EO HUD) while actively moving the head up and down to evaluate the visual system, while altering the vestibular and somatosensory system. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
Center of Pressure and sway EYES CLOSED HEAD UP AND DOWN
Time frame: 30 minutes after caffeine or energy drink consumption
Eyes Closed (MAT EC HUD) while actively moving the head up and down (in this test all three systems were altered). The same frequency of motion used for BALT's 3 and 4 in the stable surface (one spin per second, 60 BPM) was maintained for the BALT's with HUD movements on the unstable surface. This study used (Boston, MA) a pressure platform containing sensors that measure a displacement of the center of pressure in centimeters squared (cm2) (CoP), anteroposterior (AP), and mediolateral (ML) sway in centimeters (cm). The data collected from the pressure mat was analyzed with Sway Analysis Module (SAM) software designed for this purpose.
3 secondary outcomes
Body Mass Index
Time frame: Pre Balance Test-Assessment
Weight
Time frame: Pre Balance Test-Assessment
Height
Time frame: Pre Balance Test-Assessment
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 Nov 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine versus Energy Drink in people with Disorder, run by Texas Woman's University at 1 site in Puerto Rico.
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 7 inclusion and 14 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 Nov 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 Puerto Rico. 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?
Center of Pressure and sway EYES OPEN (time frame: 30 minutes after caffeine or energy drink consumption). 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 Nov 2017.