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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet | Experimental | Mediterranean diet twice per day for four weeks |
|
| Conventional diet | Placebo Comparator | Conventional diet for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet | Behavioral | Diet instruction and menu samples from the dietitian on following the Mediterranean Diet. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Won Lee, MD.PhD | Contact | 82-2-2019-3480 | indi5645@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Ji Won Lee, MD.PhD | Gangnam Severance Hospital, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |