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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03495336
Date of registration: 17/03/2018
Prospective Registration: No
Primary sponsor: Eastern Mediterranean University
Public title: The Effects of Unfiltered (Turkish) Coffee Consumption on Cardiovascular Risk Parameters
Scientific 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
Date of first enrolment: March 22, 2017
Target sample size: 28
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03495336
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Cyprus
Contacts
Name:     Tanju Besler, Prof.
Address: 
Telephone:
Email:
Affiliation:  Eastern Mediterranean University
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 35 Years
Gender: All
Health Condition(s) or Problem(s) studied
Cardiovascular Diseases
Intervention(s)
Other: LR Coffee consumption
Other: DR Coffee consumption
Other: coffee abstention phase
Primary Outcome(s)
Comparing the serum lipid levels of all interventions [Time Frame: 12 weeks]
Secondary Outcome(s)
Comparing the waist circumference (cm) 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 blood pressure (BP) (Systolic and Diastolic blood pressure (mmHg)) of all interventions [Time Frame: 12 weeks]
Comparing the weight (kg) of all interventions [Time Frame: 12 weeks]
Comparing the body fat percentage (%) of all interventions [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]
Comparing the body mass index (BMI) of all interventions [Time Frame: 12 weeks]
Comparing the height (cm) of all interventions [Time Frame: 12 weeks]
Secondary ID(s)
EasternMedU
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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