DyslipidemiasNCT04486664
Effect of Mediterranean Diet in Dyslipidemic Patients
A study testing Mediterranean Diet in people with Dyslipidemias, run by Gangnam Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Apr 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
Ji-Won Lee, 82-2-2019-4601, indi5645@yuhs.ac
About this study
Official title: 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.
- Conditions
- Dyslipidemias
- Being tested
- Mediterranean Diet
- Keywords
- dyslipidemia, mediterranean diet, microbiome, inflammation, metabolic risk
- Medical subject headings
- Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean DietBehavioural
Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Experimental | Mediterranean diet twice per day for four weeks Receives: Behavioral: Mediterranean Diet |
| Conventional diet | Placebo comparator | Conventional diet for four weeks Receives: Behavioral: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
body weight (kg)
Measured: baseline, 4 weeks, 10 weeks
Change in fat mass
fat mass (kg) measured by bioelectrical impedance analyzer
Measured: baseline, 4 weeks, 10 weeks
Change in muscle mass
muscle mass (kg) measured by bioelectrical impedance analyzer
Measured: baseline, 4 weeks, 10 weeks
Change in leukocyte count
leukocyte count (/μL)
Measured: baseline, 4 weeks, 10 weeks
Change in C-reactive protein
C-reactive protein (mg/L)
Measured: baseline, 4 weeks, 10 weeks
Change in fasting glucose
fasting glucose (mg/dL)
Measured: baseline, 4 weeks, 10 weeks
Change in insulin
insulin (mcIU/mL)
Measured: baseline, 4 weeks, 10 weeks
Secondary outcomes (5)
Change in triglyceride
triglyceride (mg/dL)
Measured: baseline, 4 weeks, 10 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
HDL-cholesterol (mg/dL)
Measured: baseline, 4 weeks, 10 weeks
Change in low-density lipoprotein cholesterol (LDL-cholesterol)
LDL-cholesterol (mg/dL)
Measured: baseline, 4 weeks, 10 weeks
Change in gut microbiome
Gut microbiome
Measured: baseline, 4 weeks, 10 weeks
Change in metabolomic response
metabolomic profile of lipid metabolism
Measured: baseline, 4 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start24 Apr 2020
- Primary completion30 Oct 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Won Lee, Gangnam Severance Hospital
- Investigators
- Ji Won Lee, MD.PhD, Principal investigator, Gangnam Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486664
- Sponsor's protocol ID
- 3-2020-0030
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mediterranean Diet on Metabolic Parameters and Microbiome in Dyslipidemic Patients: Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT04486664
- Acronym / sponsor ID
- 3-2020-0030
- Conditions
- Dyslipidemias
- Keywords
- dyslipidemia, mediterranean diet, microbiome, inflammation, metabolic risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Experimental | Behavioral: Mediterranean DietMediterranean diet twice per day for four weeks |
| Conventional diet | Placebo comparator | Behavioral: Mediterranean DietConventional diet for four weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean DietDiet instruction and menu samples from the dietitian on following the Mediterranean Diet. | Behavioural | Conventional diet, Mediterranean diet |
Primary outcome
Change in body weight
Time frame: baseline, 4 weeks, 10 weeks
body weight (kg)
Change in fat mass
Time frame: baseline, 4 weeks, 10 weeks
fat mass (kg) measured by bioelectrical impedance analyzer
Change in muscle mass
Time frame: baseline, 4 weeks, 10 weeks
muscle mass (kg) measured by bioelectrical impedance analyzer
Change in leukocyte count
Time frame: baseline, 4 weeks, 10 weeks
leukocyte count (/μL)
Change in C-reactive protein
Time frame: baseline, 4 weeks, 10 weeks
C-reactive protein (mg/L)
Change in fasting glucose
Time frame: baseline, 4 weeks, 10 weeks
fasting glucose (mg/dL)
Change in insulin
Time frame: baseline, 4 weeks, 10 weeks
insulin (mcIU/mL)
5 secondary outcomes
Change in triglyceride
Time frame: baseline, 4 weeks, 10 weeks
Change in high-density lipoprotein cholesterol (HDL-cholesterol)
Time frame: baseline, 4 weeks, 10 weeks
Change in low-density lipoprotein cholesterol (LDL-cholesterol)
Time frame: baseline, 4 weeks, 10 weeks
Change in gut microbiome
Time frame: baseline, 4 weeks, 10 weeks
Change in metabolomic response
Time frame: baseline, 4 weeks, 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Won Lee, MD.PhD principal investigator
Gangnam Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet in people with Dyslipidemias, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Won Lee, MD.PhD (82-2-2019-3480, indi5645@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: baseline, 4 weeks, 10 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.