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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01124071




Registration number
NCT01124071
Ethics application status
Date submitted
22/04/2010
Date registered
14/05/2010
Date last updated
14/05/2010

Titles & IDs
Public title
Korean Diet Efficacy Clinical Trial
Scientific 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.
Secondary ID [1] 0 0
11-2009/12124
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Provision of 2 Korean meals per day 6 days per week
Behaviour - Western Diet

Active Comparator: Korean Diet - Provision of 2 Korean meals per day, 6 days per week

Active Comparator: Western Diet - Lifestyle counseling, dietary advice, grocery vouchers


Behaviour: 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.

Behaviour: 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 code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1. To investigate the acceptability of a Korean diet in overweight and obese Australians.
Timepoint [1] 0 0
13 weeks
Primary outcome [2] 0 0
2. To examine the differences in weight loss between the Korean diet intervention and the Western diet intervention in overweight and obese Australians.
Timepoint [2] 0 0
13 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
13 weeks

Eligibility
Key inclusion criteria
- Residents of metropolitan Sydney

- Aged 18-65 years

- BMI 25-45kg/m2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2011
Actual
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Inje University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Korea Agro-Fisheries Trade Corporation, Seoul, Korea
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ministry for Food, Agriculture, Forestry and Fisheries, Korea
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01124071
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01124071