Korean Diet Efficacy Clinical Trial

Study Overview
=================
Brief Summary
-----------------
To determine: the acceptability of a Korean diet to an Australian overweight and obese population which Korean recipes are easily prepared 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.

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.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Provision of 2 Korean meals per day 6 days per week
* Behavioral: Western Diet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Korean Diet<br>Provision of 2 Korean meals per day, 6 days per week | Behavioral: Provision of 2 Korean meals per day 6 days per week<br>* 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.<br>|
| Active Comparator: Western Diet<br>Lifestyle counseling, dietary advice, grocery vouchers | Behavioral: Western Diet<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To investigate the acceptability of a Korean diet in overweight and obese Australians. | 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. | 13 weeks | 
| 2. To examine the differences in weight loss between the Korean diet intervention and the Western diet intervention in overweight and obese Australians. | This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change. | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Korean Diet