Clinical trial NCT03495336: The Effects of Unfiltered (Turkish) Coffee Consumption on Cardiovascular Risk Parameters
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Boiled coffee
Cardiovascular disease
Cholesterol
Homocysteine
Turkish coffee
Diterpenes
Unfiltered coffee
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Comparing the serum lipid levels of all interventions
timeFrame: 12 weeks
Secondary outcomes:
measure: Comparing the weight (kg) of all interventions
timeFrame: 12 weeks
measure: Comparing the height (cm) of all interventions
timeFrame: 12 weeks
measure: Comparing the body mass index (BMI) of all interventions
timeFrame: 12 weeks
measure: Comparing the body fat percentage (%) of all interventions
timeFrame: 12 weeks
measure: Comparing the waist circumference (cm) of all interventions
timeFrame: 12 weeks
measure: Comparing the blood pressure (BP) (Systolic and Diastolic blood pressure (mmHg)) of all interventions
timeFrame: 12 weeks
measure: Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention
timeFrame: 12 weeks
measure: Comparing the physical activity levels of each intervention
timeFrame: 12 weeks
measure: Comparing the Homocysteine levels of all interventions
timeFrame: 12 weeks
measure: Comparing the fasting blood glucose levels of all interventions
timeFrame: 12 weeks
measure: Comparing the serum Malondialdehyde levels of all interventions
timeFrame: 12 weeks
Other outcomes:
measure: Analysis of the content of the diterpenes (cafestol and kahweol) (mg/55mL) in LR and DR Turkish coffee brews
timeFrame: 3 months
measure: Analysis of the content of the caffeine (mg/mL) in LR and DR Turkish coffee brews
timeFrame: 3 months
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterrenean University
Study officials:
affiliation: Eastern Mediterranean University
name: Tanju Besler, Prof.
role: STUDY_CHAIR
References: