Effect of Mediterranean Diet in Dyslipidemic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Mediterranean Diet on Metabolic Parameters and Microbiome in Dyslipidemic Patients: Randomized Crossover Clinical Trial

Conditions
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Dyslipidemias

Intervention / Treatment
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* Behavioral: Mediterranean Diet


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean diet<br>Mediterranean diet twice per day for four weeks | Behavioral: Mediterranean Diet<br>* Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.<br>|
| Placebo Comparator: Conventional diet<br>Conventional diet for four weeks | Behavioral: Mediterranean Diet<br>* Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | body weight (kg) | baseline, 4 weeks, 10 weeks | 
| Change in fat mass | fat mass (kg) measured by bioelectrical impedance analyzer | baseline, 4 weeks, 10 weeks | 
| Change in muscle mass | muscle mass (kg) measured by bioelectrical impedance analyzer | baseline, 4 weeks, 10 weeks | 
| Change in leukocyte count | leukocyte count (/μL) | baseline, 4 weeks, 10 weeks | 
| Change in C-reactive protein | C-reactive protein (mg/L) | baseline, 4 weeks, 10 weeks | 
| Change in fasting glucose | fasting glucose (mg/dL) | baseline, 4 weeks, 10 weeks | 
| Change in insulin | insulin (mcIU/mL) | baseline, 4 weeks, 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in triglyceride | triglyceride (mg/dL) | baseline, 4 weeks, 10 weeks | 
| Change in high-density lipoprotein cholesterol (HDL-cholesterol) | HDL-cholesterol (mg/dL) | baseline, 4 weeks, 10 weeks | 
| Change in low-density lipoprotein cholesterol (LDL-cholesterol) | LDL-cholesterol (mg/dL) | baseline, 4 weeks, 10 weeks | 
| Change in gut microbiome | Gut microbiome | baseline, 4 weeks, 10 weeks | 
| Change in metabolomic response | metabolomic profile of lipid metabolism | baseline, 4 weeks, 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyslipidemia, mediterranean diet, microbiome, inflammation, metabolic risk