Dyslipidemias
Conditions
Keywords
dyslipidemia, mediterranean diet, microbiome, inflammation, metabolic risk
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.
Interventions
BEHAVIORALMediterranean Diet
Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin | baseline, 4 weeks, 10 weeks | insulin (mcIU/mL) |
| 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 C-reactive protein | baseline, 4 weeks, 10 weeks | C-reactive protein (mg/L) |
| Change in fasting glucose | baseline, 4 weeks, 10 weeks | fasting glucose (mg/dL) |
| Change in body weight | baseline, 4 weeks, 10 weeks | body weight (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in triglyceride | baseline, 4 weeks, 10 weeks | triglyceride (mg/dL) |
Countries
South Korea
Contacts
Primary ContactJi Won Lee, MD.PhD
Outcome results
None listed