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

NCT01724645 | Completed DMC

• 1 other identifier: CUH_KOREAN-FOOD_2-2_2010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Korean Traditional diets; hypertension; diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1C :Glycated Hemoglobin

  Glycated Hemoglobin is measured in study visits to the clinic, week 0(baseline), week 4, week 8 and week 12.

  84days

Secondary Outcomes (18)

• TG :Triglycerides

  84days

• TC :Total cholesterol

  84days

• HDL-C :High Density Lipoprotein-Cholesterol

  84days

• LDL-C : Low Density Lipoprotein-Cholesterol

  84days

• Breathing score

  84days

Other Outcomes (9)

• weight

  84days

• BMI:Body Mass Index

  84days

• Body fat percent

  84days

Study Arms (2)

Korean traditional diets

EXPERIMENTAL

Korean traditional diets (calorie 2,100kcal) for 12weeks

Dietary Supplement: Korean traditional diets

Control group

ACTIVE COMPARATOR

Control group : told to "eat as usal diet) for 12weeks

Dietary Supplement: Control group

Interventions

Korean traditional diets DIETARY_SUPPLEMENT

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.

Also known as: The Korean Traditonal diets

Korean traditional diets

Control group DIETARY_SUPPLEMENT

Told to " eat as usal diets".

Also known as: Control diets

Control group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Diabetes Mellitus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Soo-Wan Chae, MD., PhD

  Chonbuk National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 12, 2012
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

KR (1)