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Effect of Mediterranean Diet in Dyslipidemic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486664
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ji-Won Lee, Gangnam Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Behavioral: Mediterranean Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Mediterranean Diet on Metabolic Parameters and Microbiome in Dyslipidemic Patients: Randomized Crossover Clinical Trial
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : April 1, 2021

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.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: baseline, 4 weeks, 10 weeks ]
    body weight (kg)

  2. Change in fat mass [ Time Frame: baseline, 4 weeks, 10 weeks ]
    fat mass (kg) measured by bioelectrical impedance analyzer

  3. Change in muscle mass [ Time Frame: baseline, 4 weeks, 10 weeks ]
    muscle mass (kg) measured by bioelectrical impedance analyzer

  4. Change in leukocyte count [ Time Frame: baseline, 4 weeks, 10 weeks ]
    leukocyte count (/μL)

  5. Change in C-reactive protein [ Time Frame: baseline, 4 weeks, 10 weeks ]
    C-reactive protein (mg/L)

  6. Change in fasting glucose [ Time Frame: baseline, 4 weeks, 10 weeks ]
    fasting glucose (mg/dL)

  7. Change in insulin [ Time Frame: baseline, 4 weeks, 10 weeks ]
    insulin (mcIU/mL)


Secondary Outcome Measures :
  1. Change in triglyceride [ Time Frame: baseline, 4 weeks, 10 weeks ]
    triglyceride (mg/dL)

  2. Change in high-density lipoprotein cholesterol (HDL-cholesterol) [ Time Frame: baseline, 4 weeks, 10 weeks ]
    HDL-cholesterol (mg/dL)

  3. Change in low-density lipoprotein cholesterol (LDL-cholesterol) [ Time Frame: baseline, 4 weeks, 10 weeks ]
    LDL-cholesterol (mg/dL)

  4. Change in gut microbiome [ Time Frame: baseline, 4 weeks, 10 weeks ]
    Gut microbiome

  5. Change in metabolomic response [ Time Frame: baseline, 4 weeks, 10 weeks ]
    metabolomic profile of lipid metabolism



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486664


Contacts
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Contact: Ji Won Lee, MD.PhD 82-2-2019-3480 indi5645@yuhs.ac

Locations
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Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ji-Won Lee    82-2-2019-4601    indi5645@yuhs.ac   
Sponsors and Collaborators
Gangnam Severance Hospital
Investigators
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Principal Investigator: Ji Won Lee, MD.PhD Gangnam Severance Hospital Yonsei University College of Medicine
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Responsible Party: Ji-Won Lee, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT04486664    
Other Study ID Numbers: 3-2020-0030
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji-Won Lee, Gangnam Severance Hospital:
dyslipidemia
mediterranean diet
microbiome
inflammation
metabolic risk
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases