NCT03495336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

March 17, 2018

Last Update Submit

April 4, 2018

Conditions

Keywords

Boiled coffeeCardiovascular diseaseCholesterolHomocysteineTurkish coffeeDiterpenesUnfiltered coffee

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 weeks

Secondary Outcomes (11)

  • Comparing the weight (kg) of all interventions

    12 weeks

  • Comparing the height (cm) of all interventions

    12 weeks

  • Comparing the body mass index (BMI) of all interventions

    12 weeks

  • Comparing the body fat percentage (%) of all interventions

    12 weeks

  • Comparing the waist circumference (cm) of all interventions

    12 weeks

  • +6 more secondary outcomes

Other Outcomes (2)

  • Analysis of the content of the diterpenes (cafestol and kahweol) (mg/55mL) in LR and DR Turkish coffee brews

    3 months

  • Analysis of the content of the caffeine (mg/mL) in LR and DR Turkish coffee brews

    3 months

Study Arms (4)

Washout period

EXPERIMENTAL

Coffee abstention phase for 2 weeks.

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.

Other: LR Coffee consumption

Second washout period

EXPERIMENTAL

coffee abstention phase for 2 weeks

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.

Other: DR Coffee consumption

Interventions

no coffee consumption for 2 weeks

Second washout periodWashout period

for 4 weeks participants consumed only LR Turkish coffee

Light roast coffee (LR)

for 4 weeks participants consumed only DR Turkish coffee

Dark roast coffee (DR)

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterrenean University

Famagusta, 99450, Cyprus

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Tanju Besler, Prof.

    Eastern Mediterranean University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

March 17, 2018

First Posted

April 12, 2018

Study Start

March 22, 2017

Primary Completion

June 22, 2017

Study Completion

October 22, 2017

Last Updated

April 12, 2018

Record last verified: 2018-04

Locations