Clinical trial NCT01124071: Korean Diet Efficacy Clinical Trial
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Korean Diet
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Inje University
name: Korea Agro-Fisheries Trade Corporation, Seoul, Korea
name: Ministry for Food, Agriculture, Forestry and Fisheries, Korea
First posted: 2010-05-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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

Primary outcomes:
measure: 1. To investigate the acceptability of a Korean diet in overweight and obese Australians.
timeFrame: 13 weeks
measure: 2. To examine the differences in weight loss between the Korean diet intervention and the Western diet intervention in overweight and obese Australians.
timeFrame: 13 weeks
Secondary outcomes:
measure: 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.
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP
role: PRINCIPAL_INVESTIGATOR
References: