Clinical trial NCT04486664: Effect of Mediterranean Diet in Dyslipidemic Patients
Official title: Effect of Mediterranean Diet on Metabolic Parameters and Microbiome in Dyslipidemic Patients: Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyslipidemias
Keywords: dyslipidemia
mediterranean diet
microbiome
inflammation
metabolic risk
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in fat mass
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in muscle mass
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in leukocyte count
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in C-reactive protein
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in fasting glucose
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in insulin
timeFrame: baseline, 4 weeks, 10 weeks
Secondary outcomes:
measure: Change in triglyceride
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in high-density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in low-density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in gut microbiome
timeFrame: baseline, 4 weeks, 10 weeks
measure: Change in metabolomic response
timeFrame: baseline, 4 weeks, 10 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital, Yonsei University College of Medicine
name: Ji Won Lee, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: