Effect of Mediterranean Diet in Dyslipidemic Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Dyslipidemias
• Intervention / Treatment: Behavioral: Mediterranean Diet

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ji Won Lee, MD.PhD; Phone Number: 82-2-2019-3480; Email: indi5645@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Ji-Won Lee; Phone Number: 82-2-2019-4601; Email: indi5645@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mediterranean diet; Mediterranean diet twice per day for four weeks	Behavioral: Mediterranean Diet; Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
PLACEBO_COMPARATOR: Conventional diet; Conventional diet for four weeks	Behavioral: Mediterranean Diet; Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Ji Won Lee, MD.PhD, Gangnam Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2020
• Primary Completion (ANTICIPATED): October 30, 2020
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (ACTUAL): July 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: inflammation; microbiome; metabolic risk; dyslipidemia; mediterranean diet
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 3-2020-0030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No