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Korean Diet Efficacy Clinical Trial

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by University of Sydney.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124071
First Posted: May 14, 2010
Last Update Posted: May 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Inje University
Korea Agro-Fisheries Trade Corporation, Seoul, Korea
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Information provided by:
University of Sydney
April 22, 2010
May 14, 2010
May 14, 2010
January 2010
June 2010   (Final data collection date for primary outcome measure)
  • 1. To investigate the acceptability of a Korean diet in overweight and obese Australians. [ Time Frame: 13 weeks ]
    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 ]
    This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Korean Diet Efficacy Clinical Trial
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Obesity
  • 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.
  • 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.
  • Active Comparator: Korean Diet
    Provision of 2 Korean meals per day, 6 days per week
    Intervention: Behavioral: Provision of 2 Korean meals per day 6 days per week
  • Active Comparator: Western Diet
    Lifestyle counseling, dietary advice, grocery vouchers
    Intervention: Behavioral: Western Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
70
April 2011
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01124071
11-2009/12124
No
Not Provided
Not Provided
Professor Ian Caterson, Boden Institute of Obesity, Nutrition & Exercise The University of Sydney
University of Sydney
  • Inje University
  • Korea Agro-Fisheries Trade Corporation, Seoul, Korea
  • Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Principal Investigator: Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP University of Sydney
University of Sydney
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP