ObesityNCT01124071
Korean Diet Efficacy Clinical Trial
A study testing Provision of 2 Korean meals per day 6 days per week and Western Diet in people with Obesity, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Provision of 2 Korean meals per day 6 days per week and Western Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residents of metropolitan Sydney
- Aged 18-65 years
- BMI 25-45kg/m2
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
To determine:
- the acceptability of a Korean diet to an Australian overweight and obese population
- which Korean recipes are easily prepared
- the effect of a Korean diet on weight, blood pressure, and metabolic complications of obesity in this population.
Read the 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
- Being tested
- Provision of 2 Korean meals per day 6 days per week, Western Diet
- Keywords
- Korean Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of 2 Korean meals per day 6 days per weekBehavioural
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 DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Korean Diet | Active comparator | Provision of 2 Korean meals per day, 6 days per week Receives: Behavioral: Provision of 2 Korean meals per day 6 days per week |
| Western Diet | Active comparator | Lifestyle counseling, dietary advice, grocery vouchers Receives: Behavioral: Western Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To investigate the acceptability of a Korean diet in overweight and obese Australians.
This 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.
Measured: 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.
This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.
Measured: 13 weeks
Secondary outcomes (1)
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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University, Korea Agro-Fisheries Trade Corporation, Seoul, Korea, Ministry for Food, Agriculture, Forestry and Fisheries, Korea
- Investigators
- Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124071
- Sponsor's protocol ID
- 11-2009/12124
- Status last verified
- Apr 2010
- First submitted
- 22 Apr 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01124071
- Acronym / sponsor ID
- 11-2009/12124
- Conditions
- Obesity
- Keywords
- Korean Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Inje University, Korea Agro-Fisheries Trade Corporation, Seoul, Korea, Ministry for Food, Agriculture, Forestry and Fisheries, Korea
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine:
- the acceptability of a Korean diet to an Australian overweight and obese population
- which Korean recipes are easily prepared
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Korean Diet | Active comparator | Behavioral: Provision of 2 Korean meals per day 6 days per weekProvision of 2 Korean meals per day, 6 days per week |
| Western Diet | Active comparator | Behavioral: Western DietLifestyle counseling, dietary advice, grocery vouchers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Residents of metropolitan Sydney
- Aged 18-65 years
- BMI 25-45kg/m2
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of 2 Korean meals per day 6 days per weekAt 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. | Behavioural | Korean Diet |
| Western DietAt 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. | Behavioural | Western Diet |
Primary outcome
1. To investigate the acceptability of a Korean diet in overweight and obese Australians.
Time frame: 13 weeks
This 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.
Time frame: 13 weeks
This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian D Caterson, AM, MBBS, BSc(Med), PhD, FRACP principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of 2 Korean meals per day 6 days per week and Western Diet in people with Obesity, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To investigate the acceptability of a Korean diet in overweight and obese Australians. (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2010.