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CaffeineNCT06038903

The Turkish Version Of The Brief-Caffeine Expectancy Questionnaire

An observational study of Caffeine and Adaptation, run by Eskisehir Technical University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Caffeine is a psycho-active substance that is widely consumed in the world. It is seen that its widespread consumption is related to expectancies of consumption as well as cultural factors. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Caffeine, Adaptation, Expectations
What is being tested?
caffeine consumption expectation
How many people
300 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Sep 2023to 15 Oct 2023
How long will I take part?
30 Days
Phase
Observational
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Physically active, physiologically healthy and routinely caffeine consumer male and females between 18-60 ages.

Who may be able to join

  • Aged between 18 and 60
  • Physical health individuals

Who cannot join

  • Heart disease
  • Using of pacemaker
  • Epilepsy
  • Transient ischemic attack
  • Stroke or similar nervous disorders
  • Psychiatric disease
Show all 10Show fewer
  • Cardio-pulmonary diseases
  • Pregnancy
  • Drug using that affect the heart rate and blood pressure
  • Systemic, neuroplastic, inflammation disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eskişehir Technical University

    Eskişehir, Tepebaşı, 26555

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of The Psychometric Properties of The Turkish Version of The Brief-Caffeine Expectancy Questionnaire (B-CaffeQ): An Adaptation Study in Recreationally Active Individuals

Caffeine is a psycho-active substance that is widely consumed in the world. It is seen that its widespread consumption is related to expectancies of consumption as well as cultural factors. Recreationally active individuals may have various expectations from caffeine consumption in line with their lifestyles and goals such as physical, social and/or other aspects. It can be stated that caffeine consumption expectancies have an important role in the process of evaluating consumption patterns. However, in the literature it seems to be very limited information about expectancies related to caffeine consumption. In this direction, the aim of the research was to test the compatibility of Brief-Caffeine Expectancy Questionnaire (B-CaffeQ) to Turkish culture and language. In the study, data will be collected from two separate participant groups and going to analysis. To reveal the structure on the first group (n=250-300 approx.) data, Exploratory Factor Analysis (EFA), and to verify the structure on the second group (n=313) data, Confirmatory Factor Analysis (CFA) will be used. Reliability will be assessed by performing test-retest and internal consistency analyzes on both the two data groups.

Read the detailed description

INTRODUCTION

Caffeine (1,3,7-trimethylxanthine) is most commonly found in coffee as the main pharmacologically active ingredient. In general, brewed coffee has the highest content among foodstuffs containing caffeine. Coffee (230-250ml), depending on the preparation method, the type of beans, roasting, grinding type and brand, contains 35-250 mg of caffeine while tea (150 ml) 24-50 mg, cola drinks (180 ml) 15-30 mg, cocoa (150 ml) 2-7 mg, chocolate (28 g) 1-36 mg, and the foods containing chocolate mostly contain less than 15 mg caffeine.

Doses of up to 300-400mg per day in healthy adults (19 and over) are specified as safe upper limit without any harmful effects. This amount corresponds to 4-5 cups of medium coffee. However, it is stated that caffeine consumption equal to 6 cups of dark coffee generally does not cause any side effects. It is stated that the daily limit for adolescents and children is 100 mg and this limit should not be exceeded. However, coffee is not the only source of caffeine, and other sources caffeine consumed should also be taken into account.

The average daily caffeine consumption in Turkey for adolescents and children aged 15 and below is an average of 197 mg and 202 mg for 18 and older. The source of caffeine for adolescents is mostly tea, carbonated soft drinks and instant coffee consumption. Average daily caffeine consumption in adult working individuals is 247 mg, and this is due to the consumption of carbonated soft drinks, chocolate, instant coffee, respectively. It is seen that 20% of university students who consume caffeine have an average daily consumption of 250 mg and above, and this mostly due to the consumption of tea, coffee, Turkish coffee, carbonated soft drinks and chocolate. In USA, while the main source of caffeine is coffee for the age of 18 and above, it is caffeine-containing soft drinks for the age of 2-17.

There is evidence that some individuals' expectancies of caffeine's effects on physical performance and mood may affect the magnitude of these effects. There are studies showing that caffeine anticipation effect affects mood, attention, and vitality. In the case of caffeine expectancy, placebo administration stimulates changes in the dopaminergic system in the brain. The neurobiological mechanisms of caffeine and placebo caffeine were similar in the brain, but somewhat more limited in placebo caffeine. It is stated that the expectancy of the individual may manage the placebo effect and accordingly, the expected effect of caffeine or the drug consumed may change the response to placebo. Beyond the pharmacological effects of a drug, an individual's expectancies of it may also contribute to the intensive experiences of the drug in question. The fact that individuals who are told they had decaffeinated coffee but are given caffeine perform worse than those who do not consume caffeine, support the view that the pharmacological effects of caffeine act synergistically with anticipation. In addition, it has been stated that the effects caused by caffeine withdrawal may also be caused by the negative expectancies (nosebo) of an individual. These results provided evidence that the subjective and behavioral effects of caffeine consumption may be positive or negative depending on the individual's expectancies from caffeine. These expectancies may arise from the individual's previous experiences with caffeine. The effects of caffeine depend on the individual's expectancies, so if the individual consumes a beverage expecting that it has caffeine in it, these expectancies may be generalized as placebo conditions. In placebo studies, it is stated that one of the factors that cause an individual to respond to a treatment may be caused by the type of individual who may respond to treatment via expectancies. In other words, this view is not specific to the treatment of the practice applied, rather that the response may be shaped according to the expectancies of the individual, that expectancies may cause a placebo (or nosebo) effect. When there is confidence in the drug effect of a drug in a particular activity, an expectancy of a specific behavioral effect of that drug may also be formed. Based on expectancies about the effects of caffeine, the behavioral response to this drug derivative can be predicted. However, this expectancy theory is insufficient to explain the fact that some individuals without expectancies not showing stimulating effects when they consume caffeine for the first time. There are other studies which do not observe expectancy affects in caffeine consumption, suggesting placebo and expectancy effects are caused by introspection. The results showed that both pharmacological and expectancy factors affect the actual and expectancy effects of caffeine in an individual's behaviour.

Some of the performance enhancing effects of caffeine appear to be linked to expectancies. Since the bitter taste of caffeine may act as a signal that caffeine has been consumed, it seems possible that some anticipatory effects of caffeine consumption may be driven by this bitter taste. It is said that consuming 300-400 mg caffeine a day, equivalent of 3-4 cups of coffee daily, may have positive effects on the well-being of an individual and may partially improve mental-physical disorders. Performance increases were also observed with individuals who consume coffee regularly when they are given decaffeinated coffee. This suggests a caffeine related stimulus causes a caffeine related effect. This result also indicates, other features of coffee such as its smell and taste rather than caffeine itself, may also be effective in the development of these expectancies. It has been observed when these individuals who consume coffee regularly do not wish to consume caffeine yet want to benefit from its performance enhancement effects, decaffeinated coffee also creates a good effect on performance enhancement. In addition, the expectancy for the positive effects of caffeine consumption is an indicator of how much and how often caffeine will be consumed.

PURPOSE OF RESEARCH Since caffeine consumption is rather widespread in Turkey, it can be seen that an instrument to be used in research on caffeine consumption expectancies such as caffeine expectancy survey is needed. Accordingly, the purpose of this research is to adapt and verify the Breif-Caffeine Expectancy Questionnaire (B-CaffeQ) which has been developed by Kearns et al. (2018) and consists of seven dimensions: withdrawal / dependence, energy / work enhancement, appetite suppression, social / mood enhancement, physical performance enhancement, anxiety / negative physical effects, and sleep disturbance, to Turkish culture and language.

METHODOLOGY Research model

This research model includes a methodological process in which the Brief-Caffeine Expectancy Questionnaire is evaluated through the validity and reliability analysis of the Turkish language and culture. This process includes some steps will be deemed necessary for the adaptation of the questionnaire. These stages will be followed in the following order:

  • Survey translation.
  • Evaluating the items and making the necessary corrections.
  • Testing the items.
  • Creating the initial form of the questionnaire.
  • Implementation of the survey.
  • Conducting analyses.
  • Finalizing the questionnaire.
  • Examination of the measurement model.
  • Reporting of the process.

Research group The participants in this study are recreationally active individuals. Data will be collected from two different groups for validity and reliability assessments. Data will be obtained from the first group, in which the processes related to Exploratory Factor Analysis (EFA) will be carried out, and the processes related to Confirmatory Factor Analysis (CFA) will carry out with the data collected from the second group. Groups consist of participants will select by the purposive sampling. For the purpose of this research, individuals who consume products containing caffeine such as coffee, tea, and soft drinks constitute the research group. Accordingly, data will collect from 250-300 (aprroximately) participants for EFA process and from 30 participants for CFA process.

Ethical clearance The study protocol was approved by the Scientific Research and Publishing Ethics Committee of Eskisehir Technical University (Decree number: E-87914409-050.03.04-8971).

Data collection tool and technique During the data collection phase, a questionnaire form consisting of three parts will use. In the first part, explanations about the research and caffeine containing product information which the participant based their answers on included. In the second part of the questionnaire, Brief-Caffeine Expectancy Questionnaire, which is a simplified version of the caffeine expectancy questionnaire developed by Huntley and Juliano, will be included. This questionnaire, whish has been simplified by Kearns et al. (2018) by carrying out validity and reliability studies, has a 7-factor structure, consisting of 20 articles. The rating of this questionnaire, which was created in six Likert type, was defined as "1 = Strongly Disagree" to "6= Strongly Agree". In the last part of the questionnaire, there will be questions from which the demographic information of the participants such as age, gender, educational status, etc. obtain.

Aforementioned questionnaire form will be prepared on an online platform and the connection link will be provided. This link will be conveyed to participants through posts shared on these social media accounts.

Language equivalence In the process of adapting B-CaffeQ to Turkish language and culture, back translation method will be used in order to provide language equivalence. Accordingly, both the English to Turkish and Turkish to English translations will made independently by two different linguists who are adept in both languages and cultures. Finally, the articles will translate back into English and compare with their original forms.

Data analysis EFA will use in order to determine what kind of a structure pattern the survey constitutes in Turkish language and culture. CFA will use to test the accuracy of the structure resulting from EFA. Reliability tests of the questionnaire will perform through Cronbach Alpha coefficient and test-retest analysis.

Being tested
caffeine consumption expectation
Keywords
expectation, caffeine, Brief-Caffeine Expectancy Questionnaire, Language adaptation study
Medical subject headings
Language

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • caffeine consumption expectationOther

    The group to which the Short-form caffeine expectation questionnaire (B-CaffeQ) was applied, which evaluated the expectations from caffeine consumption.

Study groups in NCT06038903
Study groupRoleWhat they receive
EFA groupThis group for exploratory factor analysis (EFA)
Receives: Other: caffeine consumption expectation
CFA groupThis group for confirmatory factor analysis (CFA)
Receives: Other: caffeine consumption expectation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the Breif-Caffeine Expectancy Questionnaire (B-CaffeQ)

    Brief-Caffeine Expectancy Questionnaire, which is a simplified version of the caffeine expectancy questionnaire developed by Huntley and Juliano (2012), will be included. This questionnaire, whish has been simplified by Kearns et al. (2018) by carrying out validity and reliability studies, has a 7-factor structure, consisting of 20 articles (Huntley \& Juliano, 2012; Kearns et al., 2018). The rating of this questionnaire, which was created in six Likert type, was defined as "1 = Strongly Disagree" to "6= Strongly Agree". In the last part of the questionnaire, there will be questions from which the demographic information of the participants such as age, gender, educational status, etc. obtaine.

    Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start8 Sep 2023
  3. Primary completion10 Oct 2023
  4. Study completion15 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
300 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038903
Sponsor's protocol ID
EskisehirTU-SBF-CK-02
Status last verified
Feb 2024
First submitted
8 Sep 2023
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Caffeine and Adaptation, run by Eskisehir Technical 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 10 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 20 Feb 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?

the Breif-Caffeine Expectancy Questionnaire (B-CaffeQ) (time frame: two weeks). 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 20 Feb 2024.

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