Status:
UNKNOWN
Effect of Mediterranean Diet in Dyslipidemic Patients
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Dyslipidemias
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this randomized cross-over clinical trial is to examine the effects of Mediterranean diet based intervention on inflammation, metabolic risk and microbiome in patients with dyslipidemia...
Eligibility Criteria
Inclusion
- One or more of this criteria (total cholesterol ≥ 200mg/dl, LDL- cholesterol ≥130 mg/dL, triglyceride ≥ 200mg/dl)
- If woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug
- Able to speak and read Korean
- Able to comply with all required study procedures and schedule
- Willing and able to give written informed consent
- Participants who are not participating in other clinical trials.
Exclusion
- Participants with cancer treatment
- Participants with uncontrolled hypertension (systolic blood pressure (SBP) \>180 mmHg, or diastolic blood pressure (DBP) \>120 mmHg)
- Participants with uncontrolled diabetes or fasting glucose ≥ 200mg/dl)
- Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>3 x institutional upper limit of normal) or renal disease (serum creatinine \>2.0 mg/dL)
- Participants with significant cardiovascular disease (ischemic heart disease or stroke)
- Participants who are taking lipid-lowering medications.
- Participants who are taking other clinical trial medications.
- Participants with acute infectious disease such as pneumonia, acute gastroenteritis, and urinary tract infection.
- Vegetarian (does not eat red meat, poultry or fish)
- Participants with food allergy (sea food, fish, nuts, egg, meat, tomato, wheat, or soybean)
- Participants who are not able to eat more than 10 mediterranean meal in a row.
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04486664
Start Date
April 24 2020
End Date
April 1 2021
Last Update
July 24 2020
Active Locations (1)
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1
Gangnam Severance Hospital
Seoul, South Korea