Overview

This trial is active, not recruiting.

Condition obesity
Treatments provision of 2 korean meals per day 6 days per week, western diet
Sponsor University of Sydney
Collaborator Inje University
Start date January 2010
End date June 2010
Trial size 70 participants
Trial identifier NCT01124071, 11-2009/12124

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Provision of 2 Korean meals per day, 6 days per week
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)
Lifestyle counseling, dietary advice, grocery vouchers
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.

Primary Outcomes

Measure
1. To investigate the acceptability of a Korean diet in overweight and obese Australians.
time frame: 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.
time frame: 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.
time frame: 13 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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.
Principal investigator Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by University of Sydney.