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Korean Diet Efficacy Clinical Trial

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01124071
Enrollment
70
Registered
2010-05-14
Start date
2010-01-31
Completion date
2011-04-30
Last updated
2010-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Korean Diet

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.

Interventions

BEHAVIORALProvision 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.

BEHAVIORALWestern 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.

Sponsors

Inje University
CollaboratorOTHER
Korea Agro-Fisheries Trade Corporation, Seoul, Korea
CollaboratorUNKNOWN
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
CollaboratorOTHER_GOV
University of Sydney
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
1. To investigate the acceptability of a Korean diet in overweight and obese Australians.13 weeksThis 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.
2. To examine the differences in weight loss between the Korean diet intervention and the Western diet intervention in overweight and obese Australians.13 weeksThis will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.

Secondary

MeasureTime 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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026