Effect of Mediterranean Diet in Dyslipidemic Patients
Not Applicable
- Conditions
- Dyslipidemias
- Interventions
- Behavioral: Mediterranean Diet
- Registration Number
- NCT04486664
- Lead Sponsor
- Gangnam Severance Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Conventional diet Mediterranean Diet Conventional diet for four weeks Mediterranean diet Mediterranean Diet Mediterranean diet twice per day for four weeks
- Primary Outcome Measures
Name Time Method Change in body weight baseline, 4 weeks, 10 weeks body weight (kg)
Change in fat mass baseline, 4 weeks, 10 weeks fat mass (kg) measured by bioelectrical impedance analyzer
Change in muscle mass baseline, 4 weeks, 10 weeks muscle mass (kg) measured by bioelectrical impedance analyzer
Change in leukocyte count baseline, 4 weeks, 10 weeks leukocyte count (/μL)
Change in fasting glucose baseline, 4 weeks, 10 weeks fasting glucose (mg/dL)
Change in C-reactive protein baseline, 4 weeks, 10 weeks C-reactive protein (mg/L)
Change in insulin baseline, 4 weeks, 10 weeks insulin (mcIU/mL)
- Secondary Outcome Measures
Name Time Method Change in triglyceride baseline, 4 weeks, 10 weeks triglyceride (mg/dL)
Change in high-density lipoprotein cholesterol (HDL-cholesterol) baseline, 4 weeks, 10 weeks HDL-cholesterol (mg/dL)
Change in low-density lipoprotein cholesterol (LDL-cholesterol) baseline, 4 weeks, 10 weeks LDL-cholesterol (mg/dL)
Change in gut microbiome baseline, 4 weeks, 10 weeks Gut microbiome
Change in metabolomic response baseline, 4 weeks, 10 weeks metabolomic profile of lipid metabolism
Trial Locations
- Locations (1)
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of