Beneficial Effects of Korean Traditional Diets in Subjects With Hypertension and Type 2 Diabetes

November 9, 2012 updated by: Soo-Wan Chae, Chonbuk National University Hospital

Randomized, Open Label, Parallel Controlled, to Evaluate the Beneficial Effects of Korean Traditional Dites in Subjects With Hypertension and Type 2 Diabetes.

This trial is being conducted to look for following changes when Korean traditional diets is taken in subjects with hypertension and type 2 diabetes:

To evaluate the improvement of the controlling fasting blood glucose and glycated hemoglobin.

To assess the controlling blood pressure and heart rate.

To evaluate the influence on cardiovascular risk factor, Triglyceride, cholesterol, High Density Lipoprotein-cholesterol and Low-Density Lipoprotein-cholesterol.

To evaluate the influence on Gamma-Glutamyl Transpeptidase.

To evaluate the influence on Cardiovascular risk factor.

To evaluate the influence on valsava score, breathing score and upright score.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators aimed to investigate the efficacy of Korean traditional diets in controlling fasting blood glucose fluctuation, blood pressure, and cardiovascular risk factors in hypertensive and type 2 diabetic patients who were taking medications prescribed for respective diseases in a 12-week.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who are men and women volunteers 19~80years
  • Subject who have hypertension and type 2diabetes.
  • Subject who have taking oral medications :

(hypoglycemic, blood pressure and lipid modifying drugs).

  • Subject must provide written informed consent to participate in the study.

Exclusion Criteria:

  • Subject with a history or evidence of clinically significant gastrointestinal,anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor,psychiatric.
  • Hypertension(DBP>116mmHg or SBP>200 mmHg) having the history of cardiovascular events or taking medications known to affect lipoprotein metabolism.
  • Having Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (HbA1c >9.0%).
  • Subjects with the history of cancer.
  • Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery.
  • Having digestive, or central nervous system disorders.
  • Subject is hematologic, or neuroretinopathy.
  • Subject with uterine fibroids at ultrasonography.
  • Having severe or malignant retinopathy.
  • Having the impairment of renal and liver function, dysproteinemia, nephritic syndrome, or other renal disease.
  • Having coagulopathy
  • Having human immunodeficiency virus.
  • Having the history of mental instability and of drug and alcohol.
  • Having the history of reactions to our experimental products.
  • Participating in other clinical trials within the past 2 months.
  • Having laboratory tests, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study.
  • Having the history of alcohol or substance abuse.
  • Subject is pregnant, planning to become pregnant, or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Korean traditional diets
Korean traditional diets (calorie 2,100kcal) for 12weeks
Dietary supplement: Korean traditional diets

The consumption of Korean traditional diets reflecting the characteristics of Korean traditional diets without the limitation of calories has an effect on control of cardiovascular risk factor, so this study instructed all subjects of the intervention group to consume about 2,100kcal of served meals freely.

The Korean Traditional diets, which encourages the intake of cooked rice, vegetables,soup,Kimchi and soy fermented foods.

Other Names:
  • The Korean Traditonal diets
Active Comparator: Control group
Control group : told to "eat as usal diet) for 12weeks
Dietary supplement: Control group
Told to " eat as usal diets".
Other Names:
  • Control diets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1C :Glycated Hemoglobin
Time Frame: 84days
Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TG :Triglycerides
Time Frame: 84days
Triglycerides is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
TC :Total cholesterol
Time Frame: 84days
Total cholesterol is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
HDL-C :High Density Lipoprotein-Cholesterol
Time Frame: 84days
HDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
LDL-C : Low Density Lipoprotein-Cholesterol
Time Frame: 84days
LDL-C is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Breathing score
Time Frame: 84days
Breathing score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Valsalva score
Time Frame: 84days
Valsalva score is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Upright score
Time Frame: 84days
Upright score is measured in study visits to the clinic, week 0(baseline) and week 12.
84days
ApoA1 :Apolipoprotein A1
Time Frame: 84days
Apolipoprotein A1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
ApoB :Apolipoprotein B
Time Frame: 84days
Apolipoprotein B is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Apo E :Apolipoprotein E
Time Frame: 84days
Apolipoprotein E is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Free fatty acid
Time Frame: 84days
Free fatty acid is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Adiponectin
Time Frame: 84days
Adiponectin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
PAI-1 :Plasminogen activator inhibitor type 1
Time Frame: 84days
PAI-1 is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Homocysteine
Time Frame: 84days
Homocysteine is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
FPG :Fasting plasma glucose
Time Frame: 84days
Fasting plasma glucose is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
DBP:Diastolic Blood Pressure
Time Frame: 84days
DBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
SBP:Systolic Blood Pressure
Time Frame: 84days
SBP is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Heart rate
Time Frame: 84days
Heart rate is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
weight
Time Frame: 84days
weight is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
BMI:Body Mass Index
Time Frame: 84days
BMI is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Body fat percent
Time Frame: 84days
Body fat percent is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Waist
Time Frame: 84days
Waist is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.
84days
Obesity associated gut microbiome(Bacteriodetes)
Time Frame: 84days
Bacteriodetes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Obesity associated gut microbiome(Firmicutes)
Time Frame: 84days
Firmicutes is measured in study visits to the clinic, week 0(baseline)and week 12.
84days
Hypoglycemic(oral medication)
Time Frame: 84days
Hypoglycemic oral medication is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Control blood pressure(oral medication)
Time Frame: 84days
Control blood pressure(oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days
Lipid modifying (oral medication)
Time Frame: 84days
Lipid modifying (oral medication) is measured in study 0wk, 4wk, 8wk and 12wk.
84days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CUH_KOREAN-FOOD_2-2_2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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