Obesity Clinical Trial
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.
Verified date | April 2010 |
Source | University of Sydney |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | April 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Australia | The University of Sydney | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
University of Sydney | Inje University, Korea Agro-Fisheries Trade Corporation, Seoul, Korea, Ministry for Food, Agriculture, Forestry and Fisheries, Korea |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 13 weeks | No |
Primary | 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. | 13 weeks | No |
Secondary | 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 | No |
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