Evaluation of Food Additive Contributions to Obesity - Feasibility Study 2
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 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 before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. 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
- Na
- 干预模型
- Single Group
- 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
- •routine consumption/use of (i) >/=250 ml of artificially-sweetened beverages per day and/or (ii) >/=1 gum per day
- •willingness and ability to follow the proposed dietary intervention
- •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
- •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
- •working night shifts
- •pregnancy or planned pregnancy in the next 1 year
- •uncontrolled diabetes mellitus or diabetes requiring treatment with >2 oral diabetes medications or with insulin
研究组 & 干预措施
Dietary intervention
干预措施: Dietary intervention (Other)
结局指标
主要结局
Recruitment rate
时间窗: Baseline
Proportion of meals/beverages suspected to contain the studied food additives on 3 unannounced 24-hour dietary recalls
时间窗: 2 to 4 months
Adherence to the dietary intervention
Retention rate
时间窗: 5 months
次要结局
未报告次要终点
研究者
Natalia McInnes
Associate Professor
McMaster University