Korean Diet Efficacy Clinical Trial

University of Sydney

Status: Unknown

Conditions: Obesity

Treatments: Behavioral: Western Diet; Behavioral: Provision of 2 Korean meals per day 6 days per week

Study type: Interventional

Funder types: Other

Identifiers

NCT01124071

11-2009/12124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

Korean Diet

Active Comparator group

Description:

Provision of 2 Korean meals per day, 6 days per week

Treatment:

Behavioral: Provision of 2 Korean meals per day 6 days per week

Western Diet

Active Comparator group

Description:

Lifestyle counseling, dietary advice, grocery vouchers

Treatment:

Behavioral: Western Diet