Effect of Mediterranean Diet in Dyslipidemic Patients

Yonsei University Health System (YUHS)

Status: Unknown

Conditions: Dyslipidemias

Treatments: Behavioral: Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04486664

3-2020-0030

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Mediterranean diet

Experimental group

Description:

Mediterranean diet twice per day for four weeks

Treatment:

Behavioral: Mediterranean Diet

Conventional diet

Placebo Comparator group

Description:

Conventional diet for four weeks

Treatment:

Behavioral: Mediterranean Diet