Korean Diet Efficacy Clinical Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Sydney.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Inje University
Korea Agro-Fisheries Trade Corporation, Seoul, Korea
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT01124071
First received: April 22, 2010
Last updated: May 13, 2010
Last verified: April 2010
  Purpose

To determine:

  1. the acceptability of a Korean diet to an Australian overweight and obese population
  2. which Korean recipes are easily prepared
  3. the effect of a Korean diet on weight, blood pressure, and metabolic complications of obesity in this population.

Condition Intervention
Obesity
Behavioral: Provision of 2 Korean meals per day 6 days per week
Behavioral: Western Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A 13 Week Study to Examine the Effectiveness of the Korean Diet on Weight, Blood Pressure, Metabolic Parameters and Disease Control in an Australian Overweight and Obese Population.

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • 1. To investigate the acceptability of a Korean diet in overweight and obese Australians. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    This will be determined at baseline and 4 week timepoints throughout the study by participants completing a Food Acceptability Questionnaire (FAQ). The FAQ addresses 10 components of food acceptability along a 7-point Likeart scale. The FAQ is a recognised instrument for testing food acceptability.

  • 2. To examine the differences in weight loss between the Korean diet intervention and the Western diet intervention in overweight and obese Australians. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.


Secondary Outcome Measures:
  • To investigate changes in a number of indicators of metabolic disease in both groups - including anthropometry, Blood Glucose Levels, insulin sensitivity, lipid profiles, liver function, hormone function and inflammatory markers. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: January 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Korean Diet
Provision of 2 Korean meals per day, 6 days per week
Behavioral: Provision of 2 Korean meals per day 6 days per week
At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Korean diet group will pick up lunch and evening meals Monday-Friday. Raw ingredients and cooking instructions will also be provided on friday for saturday meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.
Active Comparator: Western Diet
Lifestyle counseling, dietary advice, grocery vouchers
Behavioral: Western Diet
At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Western diet group will be provided with a Western recipe cookbook and food vouchers (weekly) to purchase the necessary ingredients for the Western meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.

Detailed Description:

The primary endpoint (Korean diet acceptability) will be assessed by reliability tested questionnaire, dietary compliance, and quantities of food returned over the 12 weeks.

Analysis of differences in weight loss will be based on all participants with a baseline and a 12-week weight assessment. In order to investigate the impact of missing data, all subjects will be analysed using last weight observation carried forward and baseline weight carried forward.

Other secondary endpoints will determine the effect of the Korean diet on blood pressure, metabolic parameters and chronic metabolic disease control in the Australian population.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Residents of metropolitan Sydney
  • Aged 18-65 years
  • BMI 25-45kg/m2

Exclusion Criteria:

  • Diabetes treated with oral medications or insulin
  • Unstable angina or recent onset of cardiovascular disease
  • Serious hepatic or renal disease
  • serum transaminases (ALT or AST) > 2.5 times upper limit of normal
  • serum creatinine > 1.5 times upper limit of normal or urinary microalbumin >40 mg/L or eGFR < 60ml/min/1.73m²
  • Alcohol or illicit drug abuse
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Serious gastrointestinal disease (inflammatory bowel disease, active peptic ulcer, recent helicobacter pylori treatment)
  • Treatment for an eating disorder, weight loss medications and other drugs that affect body weight e.g. some anti-psychotics, anti-depressants, or corticosteroids
  • Hypothyroidism defined by elevated thyroid stimulating hormone (TSH) and low free thyroxine (fT4), or current hyperthyroidism under treatment
  • Participation in another weight loss clinical trial within past 3 months
  • Individuals who have lost >10% weight within past 3 months
  • Vegetarian eating practices
  • Inability to cook or lack of facilities for home cooking
  • Inability to read and write English
  • Subjects who frequently change smoking habits or who have stopped smoking within 6 months prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124071

Locations
Australia, New South Wales
The University of Sydney
Sydney, New South Wales, Australia, 2006
Sponsors and Collaborators
University of Sydney
Inje University
Korea Agro-Fisheries Trade Corporation, Seoul, Korea
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Investigators
Principal Investigator: Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP The University of Sydney
  More Information

No publications provided

Responsible Party: Professor Ian Caterson, Boden Institute of Obesity, Nutrition & Exercise The University of Sydney
ClinicalTrials.gov Identifier: NCT01124071     History of Changes
Other Study ID Numbers: 11-2009/12124
Study First Received: April 22, 2010
Last Updated: May 13, 2010
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Sydney:
Korean Diet

ClinicalTrials.gov processed this record on October 29, 2014