Korean Diet Efficacy Clinical Trial

Obesity 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01124071
• Other study ID #: 11-2009/12124
• Status: Active, not recruiting
• Phase: N/A
• First received: April 22, 2010
• Last updated: May 13, 2010
• Start date: January 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2010
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: April 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	The University of Sydney	Sydney	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
University of Sydney	Inje University, Korea Agro-Fisheries Trade Corporation, Seoul, Korea, Ministry for Food, Agriculture, Forestry and Fisheries, Korea

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No