Effect of Mediterranean Diet in Dyslipidemic Patients

NCT04486664 | Unknown DMC

• 1 other identifier: 3-2020-0030
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Keywords

dyslipidemia; mediterranean diet; microbiome; inflammation; metabolic risk

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Change in triglyceride

  baseline, 4 weeks, 10 weeks

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

  baseline, 4 weeks, 10 weeks

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

  baseline, 4 weeks, 10 weeks

• Change in gut microbiome

  baseline, 4 weeks, 10 weeks

• Change in metabolomic response

  baseline, 4 weeks, 10 weeks

Study Arms (2)

Mediterranean diet

EXPERIMENTAL

Mediterranean diet twice per day for four weeks

Behavioral: Mediterranean Diet

Conventional diet

PLACEBO COMPARATOR

Conventional diet for four weeks

Behavioral: Mediterranean Diet

Interventions

Mediterranean Diet BEHAVIORAL

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

Conventional diet; Mediterranean diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Inflammation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ji Won Lee, MD.PhD

  Gangnam Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Won Lee, MD.PhD

CONTACT

82-2-2019-3480; indi5645@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 24, 2020
• Study Start: April 24, 2020
• Primary Completion: October 30, 2020
• Study Completion: April 1, 2021
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)