Effect of Mediterranean Diet in Dyslipidemic Patients

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486664
• Other study ID #: 3-2020-0030
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: July 2020
• Source: Gangnam Severance Hospital
• Contact: Ji Won Lee, MD.PhD
• Phone: 82-2-2019-3480
• Email: indi5645[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2021
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Behavioral:
• Mediterranean Diet
Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	body weight (kg)	baseline, 4 weeks, 10 weeks
Primary	Change in fat mass	fat mass (kg) measured by bioelectrical impedance analyzer	baseline, 4 weeks, 10 weeks
Primary	Change in muscle mass	muscle mass (kg) measured by bioelectrical impedance analyzer	baseline, 4 weeks, 10 weeks
Primary	Change in leukocyte count	leukocyte count (/µL)	baseline, 4 weeks, 10 weeks
Primary	Change in C-reactive protein	C-reactive protein (mg/L)	baseline, 4 weeks, 10 weeks
Primary	Change in fasting glucose	fasting glucose (mg/dL)	baseline, 4 weeks, 10 weeks
Primary	Change in insulin	insulin (mcIU/mL)	baseline, 4 weeks, 10 weeks
Secondary	Change in triglyceride	triglyceride (mg/dL)	baseline, 4 weeks, 10 weeks
Secondary	Change in high-density lipoprotein cholesterol (HDL-cholesterol)	HDL-cholesterol (mg/dL)	baseline, 4 weeks, 10 weeks
Secondary	Change in low-density lipoprotein cholesterol (LDL-cholesterol)	LDL-cholesterol (mg/dL)	baseline, 4 weeks, 10 weeks
Secondary	Change in gut microbiome	Gut microbiome	baseline, 4 weeks, 10 weeks
Secondary	Change in metabolomic response	metabolomic profile of lipid metabolism	baseline, 4 weeks, 10 weeks