Korean Diet Efficacy Clinical Trial

NCT ID: NCT01124071

Last Updated: 2010-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Korean Diet

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

Group Type: ACTIVE_COMPARATOR

Provision of 2 Korean meals per day 6 days per week

Intervention Type: BEHAVIORAL

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

Lifestyle counseling, dietary advice, grocery vouchers

Group Type: ACTIVE_COMPARATOR

Western Diet

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inje University

OTHER

Sponsor Role: collaborator

Korea Agro-Fisheries Trade Corporation, Seoul, Korea

UNKNOWN

Sponsor Role: collaborator

Ministry for Food, Agriculture, Forestry and Fisheries, Korea

OTHER_GOV

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

Boden Institute of Obesity, Nutrition & Exercise The University of Sydney

Principal Investigators

Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

The University of Sydney

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

11-2009/12124

Identifier Type: -

Identifier Source: org_study_id