Increased Static Postural Sway After Energy Drink Consumption

NCT03315442 | Completed

• 1 other identifier: A2540116
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder

Keywords

Fluid; Balance

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  30 minutes after caffeine or energy drink consumption

Secondary Outcomes (3)

• Body Mass Index

  Pre Balance Test-Assessment

• Weight

  Pre Balance Test-Assessment

• Height

  Pre Balance Test-Assessment

Study Arms (2)

Caffeine Group

SHAM COMPARATOR

Caffeine group consumed 200mg of caffeine one time.

Other: Caffeine versus Energy Drink

Energy Drink Group

EXPERIMENTAL

The energy drink group consumed 1 16 ounces energy drink one time.

Other: Caffeine versus Energy Drink

Interventions

Caffeine versus Energy Drink OTHER

Caffeine group consumed 200mg of caffeine one time, while the energy drink group consumed 1 16 ounces of energy drink.

Caffeine Group; Energy Drink Group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

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, Puerto Rico

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 20, 2017
• Study Start: October 21, 2016
• Primary Completion: January 21, 2017
• Study Completion: July 21, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)