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Trial record 24 of 1900 for:    Diseases | ( Map: Puerto Rico )

Increased Static Postural Sway After Energy Drink Consumption

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ClinicalTrials.gov Identifier: NCT03315442
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Martin Rosario, Texas Woman's University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Disorder Other: Caffeine versus Energy Drink Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Screening
Official Title: Increased Static Postural Sway After Energy Drink Consumption
Actual Study Start Date : October 21, 2016
Actual Primary Completion Date : January 21, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Sham Comparator: Caffeine Group
Caffeine group consumed 200mg of caffeine one time.
Other: Caffeine versus Energy Drink
Caffeine group consumed 200mg of caffeine one time, while the energy drink group consumed 1 16 ounces of energy drink.

Experimental: Energy Drink Group
The energy drink group consumed 1 16 ounces energy drink one time.
Other: Caffeine versus Energy Drink
Caffeine group consumed 200mg of caffeine one time, while the energy drink group consumed 1 16 ounces of energy drink.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: Pre Balance Test-Assessment ]
    kg/m^2

  2. Weight [ Time Frame: Pre Balance Test-Assessment ]
    kilograms

  3. Height [ Time Frame: Pre Balance Test-Assessment ]
    meters



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315442


Locations
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Puerto Rico
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, Puerto Rico, 00936
Sponsors and Collaborators
Texas Woman's University

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Responsible Party: Martin Rosario, Assistant Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT03315442     History of Changes
Other Study ID Numbers: A2540116
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin Rosario, Texas Woman's University:
Fluid
Balance

Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents