Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The effects of food additives on body weight in humans are largely unknown. This is a feasibility study in 10 obese adults who will be followed for 5 months. Eligible participants will be non-randomly assigned to 2 groups and will be taught how to limit the exposure to the studied food additives in their diet. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >/=30 kg/m2
- •willingness and ability to follow the proposed dietary interventions
- •informed consent
排除标准
- •previous or planned bariatric surgery in the next 1 year
- •current or planned participation in any structured weight-loss programs in the next 6 months
- •current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
- •excessive alcohol consumption
- •bipolar disorder or attention deficit hyperactivity disorder
- •current use of anti-depressant or anti-psychotic medications
- •eating disorder or any other active disorder that may lead to significant weight changes
- •pregnancy or planned pregnancy in the next 1 year
- •uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin
结局指标
主要结局
Recruitment rate
时间窗: 0 months
Average number of participants recruited per month
Retention rate in arm 2
时间窗: 5 months
Percent of enrolled participants who complete the study
Adherence to the dietary intervention in arm 1
时间窗: 2 to 5 months
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Adherence to the dietary intervention in arm 2
时间窗: 2 to 5 months
Proportion of meals/beverages free of the studied food additives on 3 unannounced 24-hour dietary recalls
Retention rate in arm 1
时间窗: 5 months
Percent of enrolled participants who complete the study
次要结局
未报告次要终点
研究者
Natalia McInnes
Associate Professor
McMaster University