An interventional study of coffee abstention phase and LR Coffee consumption in Cardiovascular Diseases, sponsored by Eastern Mediterranean University. Completed at 1 site in Cyprus. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-12.
Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Coffee abstention phase for 2 weeks.
Other: coffee abstention phase
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.
Other: LR Coffee consumption
coffee abstention phase for 2 weeks
Other: coffee abstention phase
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.
Other: DR Coffee consumption
no coffee consumption for 2 weeks
for 4 weeks participants consumed only LR Turkish coffee
for 4 weeks participants consumed only DR Turkish coffee
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).
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 12 weeks
Comparing the body mass index (BMI) of all interventions
BMI was calculated (weight/height squared; in kilograms per square meter)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Analysis of the content of the diterpenes (cafestol and kahweol) (mg/55mL) in LR and DR Turkish coffee brews
Cafestol and kahweol were analyzed in the unsaponified matter by HPLC-DAD. Diterpenes content of the two coffee beverages were reported as mean±standard deviation and Kruskal-Wallis test was used for statistical comparison of coffee roasts.. All analyses were performed using SPSS 24.0 (IBM-SPSS Inc., Chicago, IL, USA).
Time frame: 3 months
Analysis of the content of the caffeine (mg/mL) in LR and DR Turkish coffee brews
Caffeine was determined by high-performance liquid chromatography (HPLC, Aligent Technologies, USA) with diode-array detector (DAD) and mass spectrometer. content of the two coffee beverages were reported as mean±standard deviation and Kruskal-Wallis test was used for statistical comparison of coffee roasts.. All analyses were performed using SPSS 24.0 (IBM-SPSS Inc., Chicago, IL, USA).
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eastern Mediterranean University