NCT02117193

Brief Summary

Although the effects of acute alcohol intake and sleep deprivation on exercise performance lacks evidence in the literature, in many situations, they occur simultaneously. Once the alcohol affects physiological processes, the processes that occur during sleep can be impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM sleep. These changes promote a significant functional impairment such as a reduction in alertness and modification in reaction time, which affects the performance of any activity of daily and professional life. However, the combined effects on the physical performance variables, such as aerobic and neuromuscular performance lack of evidence in the literature.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 22, 2016

Completed
Last Updated

December 21, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

April 14, 2014

Results QC Date

May 10, 2016

Last Update Submit

October 27, 2016

Conditions

Alcohol IntakeSleep Deprivation

Outcome Measures

Primary Outcomes (3)

  • Aerobic Performance

    Aerobic performance will be determined through the subject's heart rate

    After each sequence, up to 8 hours

  • Neuromuscular Performance

    knee extensor isometric torque

    After each sequence, up to 8 hours

  • Biochemical Responses

    Glucose after each situation in the morning

    After each sequence, up to 8 hours

Secondary Outcomes (3)

  • Hydration Status

    After each sequence, up to 8 hours

  • Profile of Mood States

    6 months

  • Breath Alcohol

    6 months

Study Arms (2)

Alcohol intake

PLACEBO COMPARATOR

1 g/kg of etanol combined. Beer without alcohol in the same volume will be used to placebo condition.

Other: Alcohol intakeOther: Sleep deprivation

sleep deprivation

ACTIVE COMPARATOR

one night of sleep deprivation will be compared to 8h of normal sleep.

Other: Alcohol intakeOther: Sleep deprivation

Interventions

Alcohol intakeOTHER

The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation).

Alcohol intakesleep deprivation
Sleep deprivationOTHER

One night of sleep deprivation or one night of normal sleep.

Alcohol intakesleep deprivation

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Physical active men

You may not qualify if:

  • AUDIT questionnaire above 15 points
  • Nocturnal Chronotype
  • Skeletal muscle injuries in upper and lower limb
  • Metabolic and cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Research Laboratory

Porto Alegre, Rio Grande do Sul, 90690200, Brazil

Location

MeSH Terms

Conditions

Alcohol DrinkingSleep Deprivation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Dr Marco Aurélio Vaz
Organization
Federal University of Rio Grande do Sul
marcovaz@esef.ufrgs.br
555133085860

Study Officials

  • Rodrigo Rodrigues, MSc

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 17, 2014

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 21, 2016

Results First Posted

September 22, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)