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.
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- 1. To investigate the acceptability of a Korean diet in overweight and obese Australians.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residents of metropolitan Sydney
- •Aged 18-65 years
- •BMI 25-45kg/m2
排除标准
- •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
结局指标
主要结局
1. To investigate the acceptability of a Korean diet in overweight and obese Australians.
时间窗: 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.
时间窗: 13 weeks
This will be determined by assessing differences at baseline and 12 weeks for weight, BMI and percent BMI change.
次要结局
- 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)