Cardiovascular DiseasesNCT03495336
The Effects of Unfiltered (Turkish) Coffee Consumption on Cardiovascular Risk Parameters
A study testing coffee abstention phase, LR Coffee consumption and DR Coffee consumption in people with Cardiovascular Diseases, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Purpose/Objective: The aim of this study is to investigate the impact of boiled unfiltered (Turkish) coffee consumption on the plasma cardiovascular risk parameters of healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- coffee abstention phase, LR Coffee consumption and DR Coffee consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCyprus
- Study dates
- 22 Mar 2017to 22 Oct 2017
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular Turkish coffee consumer ≥ 1 cups/day
- Body mass index (BMI) 18.5-24.9 kg/m2 )
- Non-smoker or former smoker (more than a year)
- Willingness to abstain from coffee drinking
- Willingness to consume ≥ 3 cups/day of Turkish coffee
Who cannot join
- Acute or chronic diseases
- Severe illness with in-patient treatment during last 3 months
- Use of regular medication or any supplements
- Weight reduction ˃2 kg/week during the last month
- Pregnancy or breastfeeding
- Regular strong physical activity with ≥1h/day
Show all 10Show fewer
- High alcohol intake a weekly intake of ˃7 units for women and ˃14units for men
- Excess consumption of total fat ˃35% of daily calories
- Consumption of saturated fatty acid ˃10% of daily calories
- Cholesterol intake ˃300mg/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-week Consumption of Light or Dark Roast Unfiltered (Turkish) Coffee Affects Cardiovascular Risk Parameters of Homocysteine and Cholesterol Concentrations in Healthy Subjects: A Randomized Crossover Clinical Trial
Purpose/Objective: The aim of this study is to investigate the impact of boiled unfiltered (Turkish) coffee consumption on the plasma cardiovascular risk parameters of healthy subjects. The study also explores whether two unfiltered boiled (Turkish) coffee beverages that differ in content due to different roasting degrees will differentially affect cardiovascular biomarkers.
Methods: In this crossover intervention study, healthy, nonsmoking, habitual Turkish coffee drinkers (n=28) were randomized to consume at least 3 cups of Light (LR) or Dark (DR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. Subsequent to each coffee abstinence period, both groups received the alternative intervention. After the first WO and the coffee intervention periods, anthropometric measures, blood pressure, heart rate and 13 biochemical parameters were collected and dietary records were completed.
Read the detailed description
Background: Considerable controversy exists regarding the link between coffee consumption and cardiovascular disease (CVD) risk. It has been shown that different coffee preparation and brewing methods influence the concentration of compounds present in the final coffee brew. Unlike coffee traditionally consumed in the western world, Turkish coffee is not drip filtered, but rather its method of preparation involves slowly boiling water that is mixed with thinly ground coffee beans. This style of preparation results in a greater amount of biologically active components (caffeine and diterpenes) remaining in the liquid. In addition to preparation styles, roasting process greatly affects the chemical composition of the coffee. Coffee types differing in content of major constituents differ with regard to cardiovascular health effects.
Purpose/Objective: The aim of this study is to investigate the impact of boiled unfiltered (Turkish) coffee consumption on the plasma cardiovascular risk parameters of healthy subjects. The study also explores whether two unfiltered boiled (Turkish) coffee beverages that differ in content due to different roasting degrees will differentially affect cardiovascular biomarkers.
Methods: In this crossover intervention study, healthy, nonsmoking, habitual Turkish coffee drinkers (n=28) were randomized to consume at least 3 cups of Light (LR) or Dark (DR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. Subsequent to each coffee abstinence period, both groups received the alternative intervention. After the first WO and the coffee intervention periods, anthropometric measures, blood pressure, heart rate and 13 biochemical parameters were collected and dietary records were completed.
- Conditions
- Cardiovascular Diseases
- Being tested
- coffee abstention phase, LR Coffee consumption, DR Coffee consumption
- Keywords
- Boiled coffee, Cardiovascular disease, Cholesterol, Homocysteine, Turkish coffee, Diterpenes, Unfiltered coffee
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coffee abstention phaseOther
no coffee consumption for 2 weeks
LR Coffee consumptionOther
for 4 weeks participants consumed only LR Turkish coffee
DR Coffee consumptionOther
for 4 weeks participants consumed only DR Turkish coffee
| Study group | Role | What they receive |
|---|---|---|
| Washout period | Experimental | Coffee abstention phase for 2 weeks. Receives: Other: coffee abstention phase |
| Light roast coffee (LR) | Experimental | Participants will follow LR Coffee consumption procedure and consume at least 3 cups of Light (LR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. Receives: Other: LR Coffee consumption |
| Second washout period | Experimental | coffee abstention phase for 2 weeks Receives: Other: coffee abstention phase |
| Dark roast coffee (DR) | Experimental | Participants will follow DR Coffee consumption procedure and consume at least 3 cups of Dark (DR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. Receives: Other: DR Coffee consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the serum lipid levels of all interventions
Differences in concentration of serum lipid levels of participants in coffee-free period (washout) and after LR or DR coffee ingestion were measured.
Blood samples were obtained at the end of two weeks washout period and after each four weeks coffee intervention period, and sera were stored at -30∘ C, until analytical measurements were performed. The levels of serum lipids: Triglycerides (mg/dL), Total cholesterol (mg/dL), and HDL cholesterol (mg/dL) were determined using a Dimension Xpand Plus integrated clinical chemistry autoanalyzer (Siemens Healthcare Diagnostics, Deerfield, IL, USA). The serum levels of LDL cholesterol (mg/dL) were calculated using Friedewald's equation. Differences in blood lipid variables were analyzed by repeated-measures ANOVA for comparisons of LR coffee intake with DR and of each roast with the washout.analyses were performed using SPSS 24.0 (IBM-SPSS Inc., Chicago, IL, USA).
Measured: 12 weeks
Secondary outcomes (11)
Comparing the weight (kg) of all interventions
Weight was measured after the washout period and after each intervention. Weight (in kilograms) was measured in light clothing, without shoes.
Measured: 12 weeks
Comparing the height (cm) of all interventions
after the washout period and after each intervention height was measured using a stadiometer to the nearest centimeter.
Measured: 12 weeks
Comparing the body mass index (BMI) of all interventions
BMI was calculated (weight/height squared; in kilograms per square meter)
Measured: 12 weeks
Comparing the body fat percentage (%) of all interventions
after the washout period and after each intervention the percentage of body fat and fat free mass (FFM) was measured by Tanita Segmental Body Composition Analyzer BC-418 MA (Tanita Corp. Tokyo, Japan)
Measured: 12 weeks
Comparing the waist circumference (cm) of all interventions
after the washout period and after each intervention waist circumferences (midway between the rib cage and the iliac crest) were measured using a flexible tape.
Measured: 12 weeks
Comparing the blood pressure (BP) (Systolic and Diastolic blood pressure (mmHg)) of all interventions
after the washout period and after each intervention BP and heart rate (beats/min) was monitored using an automatic arm sphygmomanometer (Pic Indolor Diagnostic, BS 150, Artsana, Italy) after a 5-min rest in a sitting position.
Measured: 12 weeks
Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention
Daily nutrient intake was calculated by using computer software (Ebispro, Stuttgart, Germany; Turkish version: BeBiS, Vers. 6.1)
Measured: 12 weeks
Comparing the physical activity levels of each intervention
The validated Turkish version of the International Physical Activity Questionnaire (IPAQ)-short form (7 item) was administered. The IPAQ questionnaires list activities and request estimates of durations and frequencies for each activity engaged in over the past week. Durations are multiplied by known METs per activity and the results for all items are summed for the overall physical activity score. Scores for walking and for moderate and vigorous activities are sums of corresponding item scores. A sitting question is not included in physical activity score. Physical activity level (PAL): Extremely inactive <1.40 , Sedentary 1.40-1.69, Moderately active 1.70-1.99, Vigorously active 2.00-2.40,Extremely active>2.40
Measured: 12 weeks
Comparing the Homocysteine levels of all interventions
Differences in concentration of homocysteine (μmol/L) levels of participants after 2wk coffee-free period (washout) and after 4 weeks of LR or DR coffee ingestion was compared. EDTA-treated blood samples for total homocysteine (μmol/L) analysis were immediately refrigerated (placed on ice) until the plasma was separated by centrifugation. All the samples were assayed for Homocysteine by using High Performance Liquid Chromatography with fluorescent detection technique (HPLC-FLD). Differences in homocysteine variables were analyzed by repeated-measures ANOVA for comparisons of LR coffee intake with DR and of each roast with the washout.analyses were performed using SPSS 24.0 (IBM-SPSS Inc., Chicago, IL, USA).
Measured: 12 weeks
Comparing the fasting blood glucose levels of all interventions
Concentration of fasting blood glucose levels in coffee-free period (washout) and changes after LR or DR coffee ingestion were compared.Blood samples were obtained at the end of two weeks washout period and after each four weeks coffee intervention period, and sera were stored at -30∘ C, until analytical measurements were performed. The levels of Fasting blood glucose (mg/dL), were determined using a Dimension Xpand Plus integrated clinical chemistry autoanalyzer (Siemens Healthcare Diagnostics, Deerfield, IL, USA). Differences in human variables were analyzed by repeated-measures ANOVA for comparisons of LR coffee intake with DR and of each roast with the washout.
Measured: 12 weeks
Comparing the serum Malondialdehyde levels of all interventions
Concentration of Serum Malondialdehyde (μM) levels at the end of coffee-free period (washout) and changes after LR or DR coffee ingestion were compared.Serum Malondialdehyde (μM) levels were determined with a colorimetric assay kit (Cayman Chemical, Ann Arbor, MI). Differences in human variables were analyzed by repeated-measures ANOVA for comparisons of LR coffee intake with DR and of each roast with the washout.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start22 Mar 2017
- Primary completion22 Jun 2017
- Study completion22 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Hülyam Eren, Eastern Mediterranean University
- Investigators
- Tanju Besler, Prof., Study chair, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495336
- Sponsor's protocol ID
- EasternMedU
- Status last verified
- Apr 2018
- First submitted
- 17 Mar 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Consumption of Light or Dark Roast Unfiltered (Turkish) Coffee Affects Cardiovascular Risk Parameters of Homocysteine and Cholesterol Concentrations in Healthy Subjects: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT03495336
- Acronym / sponsor ID
- EasternMedU
- Conditions
- Cardiovascular Diseases
- Keywords
- Boiled coffee, Cardiovascular disease, Cholesterol, Homocysteine, Turkish coffee, Diterpenes, Unfiltered coffee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 22 Oct 2017 (actual)
- First posted
- 12 Apr 2018 (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.
Purpose/Objective: The aim of this study is to investigate the impact of boiled unfiltered (Turkish) coffee consumption on the plasma cardiovascular risk parameters of healthy subjects. The study also explores whether two unfiltered boiled (Turkish) coffee beverages that differ in content due to different roasting degrees will differentially affect cardiovascular biomarkers.
Methods: In this crossover intervention study, healthy, nonsmoking, habitual Turkish coffee drinkers (n=28) were randomized to consume at least 3 cups of Light (LR) or Dark (DR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. Subsequent to each coffee abstinence period, both groups received the alternative intervention. After the first WO and the coffee intervention periods, anthropometric measures, blood pressure, heart rate and 13 biochemical parameters were collected and dietary records were completed.
Detailed description
Background: Considerable controversy exists regarding the link between coffee consumption and cardiovascular disease (CVD) risk. It has been shown that different coffee preparation and brewing methods influence the concentration of compounds present in the final coffee brew. Unlike coffee traditionally consumed in the western world, Turkish coffee is not drip filtered, but rather its method of preparation involves slowly boiling water that is mixed with thinly ground coffee beans. This style of preparation results in a greater amount of biologically active components (caffeine and diterpenes) remaining in the liquid. In addition to preparation styles, roasting process greatly affects the chemical composition of the coffee. Coffee types differing in content of major constituents differ with regard to cardiovascular health effects.
Purpose/Objective: The aim of this study is to investigate the impact of boiled unfiltered (Turkish) coffee consumption on the plasma cardiovascular risk parameters of healthy subjects. The study also explores whether two unfiltered boiled (Turkish) coffee beverages that differ in content due to different roasting degrees will differentially affect cardiovascular biomarkers.
Methods: In this crossover intervention study, healthy, nonsmoking, habitual Turkish coffee drinkers (n=28) were randomized to consume at least 3 cups of Light (LR) or Dark (DR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. Subsequent to each coffee abstinence period, both groups received the alternative intervention. After the first WO and the coffee intervention periods, anthropometric measures, blood pressure, heart rate and 13 biochemical parameters were collected and dietary records were completed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Washout period | Experimental | Other: coffee abstention phaseCoffee abstention phase for 2 weeks. |
| Light roast coffee (LR) | Experimental | Other: LR Coffee consumptionParticipants will follow LR Coffee consumption procedure and consume at least 3 cups of Light (LR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. |
| Second washout period | Experimental | Other: coffee abstention phasecoffee abstention phase for 2 weeks |
| Dark roast coffee (DR) | Experimental | Other: DR Coffee consumptionParticipants will follow DR Coffee consumption procedure and consume at least 3 cups of Dark (DR) roast Turkish coffee brews per day for 4 weeks after a washout period (WO) of 2 weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Regular Turkish coffee consumer ≥ 1 cups/day
- Body mass index (BMI) 18.5-24.9 kg/m2 )
- Non-smoker or former smoker (more than a year)
- Willingness to abstain from coffee drinking
- Willingness to consume ≥ 3 cups/day of Turkish coffee
Key exclusion criteria (10 listed)
- Acute or chronic diseases
- Severe illness with in-patient treatment during last 3 months
- Use of regular medication or any supplements
- Weight reduction ˃2 kg/week during the last month
- Pregnancy or breastfeeding
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 |
|---|---|---|
| coffee abstention phaseno coffee consumption for 2 weeks | Other | Second washout period, Washout period |
| LR Coffee consumptionfor 4 weeks participants consumed only LR Turkish coffee | Other | Light roast coffee (LR) |
| DR Coffee consumptionfor 4 weeks participants consumed only DR Turkish coffee | Other | Dark roast coffee (DR) |
Primary outcome
Comparing the serum lipid levels of all interventions
Time frame: 12 weeks
Differences in concentration of serum lipid levels of participants in coffee-free period (washout) and after LR or DR coffee ingestion were measured. Blood samples were obtained at the end of two weeks washout period and after each four weeks coffee intervention period, and sera were stored at -30∘ C, until analytical measurements were performed. The levels of serum lipids: Triglycerides (mg/dL), Total cholesterol (mg/dL), and HDL cholesterol (mg/dL) were determined using a Dimension Xpand Plus integrated clinical chemistry autoanalyzer (Siemens Healthcare Diagnostics, Deerfield, IL, USA). The serum levels of LDL cholesterol (mg/dL) were calculated using Friedewald's equation. Differences in blood lipid variables were analyzed by repeated-measures ANOVA for comparisons of LR coffee intake with DR and of each roast with the washout.analyses were performed using SPSS 24.0 (IBM-SPSS Inc., Chicago, IL, USA).
11 secondary outcomes
Comparing the weight (kg) of all interventions
Time frame: 12 weeks
Comparing the height (cm) of all interventions
Time frame: 12 weeks
Comparing the body mass index (BMI) of all interventions
Time frame: 12 weeks
Comparing the body fat percentage (%) of all interventions
Time frame: 12 weeks
Comparing the waist circumference (cm) of all interventions
Time frame: 12 weeks
Comparing the blood pressure (BP) (Systolic and Diastolic blood pressure (mmHg)) of all interventions
Time frame: 12 weeks
Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention
Time frame: 12 weeks
Comparing the physical activity levels of each intervention
Time frame: 12 weeks
Comparing the Homocysteine levels of all interventions
Time frame: 12 weeks
Comparing the fasting blood glucose levels of all interventions
Time frame: 12 weeks
Comparing the serum Malondialdehyde levels of all interventions
Time frame: 12 weeks
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 12 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Tanju Besler, Prof. study chair
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coffee abstention phase, LR Coffee consumption and DR Coffee consumption in people with Cardiovascular Diseases, run by Eastern Mediterranean University at 1 site in Cyprus.
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 5 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 12 Apr 2018. 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 Cyprus. 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?
Comparing the serum lipid levels of all interventions (time frame: 12 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 12 Apr 2018.