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Effect of Mediterranean Diet in Dyslipidemic Patients

Primary Purpose

Dyslipidemias

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Mediterranean Diet

About this trial

This is an interventional prevention trial for Dyslipidemias focused on measuring dyslipidemia, mediterranean diet, microbiome, inflammation, metabolic risk

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Gangnam Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mediterranean diet

Conventional diet

Arm Description

Mediterranean diet twice per day for four weeks

Conventional diet for four weeks

Outcomes

Primary Outcome Measures

Change in body weight

body weight (kg)

Change in fat mass

fat mass (kg) measured by bioelectrical impedance analyzer

Change in muscle mass

muscle mass (kg) measured by bioelectrical impedance analyzer

Change in leukocyte count

leukocyte count (/μL)

Change in C-reactive protein

C-reactive protein (mg/L)

Change in fasting glucose

fasting glucose (mg/dL)

Change in insulin

insulin (mcIU/mL)

Secondary Outcome Measures

Change in triglyceride

triglyceride (mg/dL)

Change in high-density lipoprotein cholesterol (HDL-cholesterol)

HDL-cholesterol (mg/dL)

Change in low-density lipoprotein cholesterol (LDL-cholesterol)

LDL-cholesterol (mg/dL)

Change in gut microbiome

Gut microbiome

Change in metabolomic response

metabolomic profile of lipid metabolism

Full Information

NCT ID

NCT04486664

First Posted

July 22, 2020

Last Updated

July 22, 2020

Sponsor

Gangnam Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04486664

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 24, 2020 (Actual)

Primary Completion Date

October 30, 2020 (Anticipated)

Study Completion Date

April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias

Keywords

dyslipidemia, mediterranean diet, microbiome, inflammation, metabolic risk

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mediterranean diet

Arm Type

Experimental

Arm Description

Mediterranean diet twice per day for four weeks

Arm Title

Conventional diet

Arm Type

Placebo Comparator

Arm Description

Conventional diet for four weeks

Intervention Type

Behavioral

Intervention Name(s)

Mediterranean Diet

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in body weight

Description

body weight (kg)

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in fat mass

Description

fat mass (kg) measured by bioelectrical impedance analyzer

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in muscle mass

Description

muscle mass (kg) measured by bioelectrical impedance analyzer

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in leukocyte count

Description

leukocyte count (/μL)

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in C-reactive protein

Description

C-reactive protein (mg/L)

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in fasting glucose

Description

fasting glucose (mg/dL)

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in insulin

Description

insulin (mcIU/mL)

Time Frame

baseline, 4 weeks, 10 weeks

Secondary Outcome Measure Information:

Title

Change in triglyceride

Description

triglyceride (mg/dL)

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in high-density lipoprotein cholesterol (HDL-cholesterol)

Description

HDL-cholesterol (mg/dL)

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in low-density lipoprotein cholesterol (LDL-cholesterol)

Description

LDL-cholesterol (mg/dL)

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in gut microbiome

Description

Gut microbiome

Time Frame

baseline, 4 weeks, 10 weeks

Title

Change in metabolomic response

Description

metabolomic profile of lipid metabolism

Time Frame

baseline, 4 weeks, 10 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ji Won Lee, MD.PhD

Phone

82-2-2019-3480

indi5645@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ji Won Lee, MD.PhD

Organizational Affiliation

Gangnam Severance Hospital, Yonsei University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gangnam Severance Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ji-Won Lee

Phone

82-2-2019-4601

indi5645@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Mediterranean Diet in Dyslipidemic Patients

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