NCT06561113

Brief Summary

Although the effects of different doses of caffeine on balance have been evaluated in various studies, the effects of low doses of caffeine ingested with Turkish coffee on postural control and hand-eye coordination remain unclear. In this study, it will be investigated the acute effects of 60 mg caffeine intake via Turkish coffee on postural control and hand-eye coordination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

9 days

First QC Date

August 13, 2024

Last Update Submit

August 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postural control assessment with Biodex Balance System

    Postural control evaluation will be performed with "Biodex Balance System" (Shirley, NY). Three tests will be performed with the device: postural stability test, stability limits test, and the Modified Clinical Test for Sensory Interaction and Balance (mCTSIB). The test will then continue for 30 seconds, during which time the number of balls caught will be noted

    Baseline and immediately after caffeine intake

Secondary Outcomes (1)

  • Hand-eye coordination assessment with alternate hand-wall toss test

    Baseline and immediately after caffeine intake

Study Arms (1)

Study group

EXPERIMENTAL

Participants who meet the inclusion and exclusion criteria will undergo postural control assessment with the Biodex Balance System® and hand-eye coordination test with the Alternate Hand Wall Toss Test. Subjects will be given 65 ml of Turkish coffee (one cup) to ensure oral caffeine intake. The same assessments will be repeated 30 minutes after caffeine intake.

Other: Caffeine intake

Interventions

One cup of Turkish coffee contains 60 mg/65 ml (1 Turkish coffee cup) of caffeine. Participants will be instructed to sit for 10 minutes before drinking coffee. To prepare the Turkish coffee, 5 g of ground dry coffee will be mixed in 100 mL of tap water and left to boil in a coffee machine. When the first boil starts, it will be removed from the machine and poured into the cup. Then, 65 ml of Turkish coffee will be given to the subjects to ensure oral caffeine intake.

Study group

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being 18-26 years of age
  • Having a normal body mass index

You may not qualify if:

  • Having a health problem that prevented caffeine intake
  • Having a diagnosis of vestibular and neurological disease
  • Using drugs that affect the central nervous system
  • Using any medication related to chronic disease
  • Having lower extremity rotational alignment disorder
  • Having a history of lower and/or upper extremity injury or surgery in the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Deniz Tuncer

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 19, 2024

Study Start

August 14, 2024

Primary Completion

August 23, 2024

Study Completion

August 23, 2024

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations