CaffeineNCT06561113
The Effect of Turkish Coffee on Postural Control and Hand-eye Coordination in Young Adults
A study testing Caffeine intake in people with Caffeine and Balance; Distorted, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Balance; Distorted, Coordination and Balance Disturbances
- What is being tested?
- Caffeine intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2024to 23 Aug 2024
- 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 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18-26 years of age
- Having a normal body mass index
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Cup of Turkish Coffee Affect Postural Control and Hand-eye Coordination in Young Adults? A Quasi-experimental Study
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.
Read the detailed description
This study is designed as a one-group pretest-posttest quasi-experimental research. The study will be conducted with healthy young adults with low coffee consumption habits. 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.
- Being tested
- Caffeine intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine intakeOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Caffeine intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and immediately after caffeine intake
Secondary outcomes (1)
Hand-eye coordination assessment with alternate hand-wall toss test
Alternate hand wall toss test will be used to measure hand-eye coordination. The Alternate-Hand Wall-Toss Test is a test of hand-eye coordination, where the participant throw a ball against a wall from one hand in an underarm action, and attempt to catch it with the opposite hand. The test will then continue for 30 seconds, during which time the number of balls caught will be noted.
Measured: Baseline and immediately after caffeine intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start14 Aug 2024
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561113
- Sponsor's protocol ID
- 29.07.2024-159880
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Cup of Turkish Coffee Affect Postural Control and Hand-eye Coordination in Young Adults? A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06561113
- Acronym / sponsor ID
- 29.07.2024-159880
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 19 Aug 2024 (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.
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.
Detailed description
This study is designed as a one-group pretest-posttest quasi-experimental research. The study will be conducted with healthy young adults with low coffee consumption habits. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Caffeine intakeParticipants 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being 18-26 years of age
- Having a normal body mass index
Key exclusion criteria (6 listed)
- 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
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 intakeOne 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. | Other | Study group |
Primary outcome
Postural control assessment with Biodex Balance System
Time frame: Baseline and immediately after caffeine intake
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
1 secondary outcome
Hand-eye coordination assessment with alternate hand-wall toss test
Time frame: Baseline and immediately after caffeine intake
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 26 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 intake in people with Caffeine and Balance; Distorted, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 26 Aug 2024. 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 Turkey (Türkiye). 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. 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?
Postural control assessment with Biodex Balance System (time frame: Baseline and immediately after caffeine intake). 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 26 Aug 2024.