A Pilot Study: Snacking, Willpower and Glucose Availability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Responses to the Control of Eating Questionnaire
研究概览
简要总结
To compare the effects of ingesting 100, 50 and 10 calories of glucose as compared to a non-calorie placebo (0 calorie beverage) on self-control over resisting snack foods. To test whether there is a threshold of glucose that will result in improved ease of resistance to problem foods (tested by comparing three different levels of glucose).
详细描述
Ingestion of 100 calories of glucose during individually pre-determined times of waning dietary self-control will result in improved ease of resistance to problem foods when compared to ingestion of lower calories of glucose or placebo (0 calorie beverage)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females ages 18 - 65 years.
- •Self-identify as regular snackers, with a specific problem food, who have trouble with over-consuming this snack food.
- •Have intentionally lost weight in the last year and are seeking to maintain that weight loss or have unintentionally gained weight in the last year and are concerned about it.
- •Generally healthy.
排除标准
- •Pregnant or trying to become pregnant.
- •Diagnosis of type 1 or type 2 diabetes
- •Not willing or able to follow study guidelines (ie: consuming the study beverage daily for four weeks, or completing daily compliance logs)
- •Current smoker (or has stopped smoking within the last 6 months)
- •Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents, etc).
- •Current or history of eating disorder (anorexia, bulimia, or diagnosed binge eating disorder)
- •Current alcohol or drug abuse or dependence
- •Any medical condition for which daily snacking of such problem foods would be inadvisable (i.e.: a subject with hypertension advised to avoid sodium).
研究组 & 干预措施
Sequence 1 (D-B-A-C)
100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
干预措施: Sequence 1 (Dietary Supplement)
Sequence 2 (A-D-C-B)
Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
干预措施: Sequence 2 (Dietary Supplement)
Sequence 3 (C-A-B-D)
50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
干预措施: Sequence 3 (Dietary Supplement)
Sequence 4 (B-C-D-A)
10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
干预措施: Sequence 4 (Dietary Supplement)
结局指标
主要结局
Responses to the Control of Eating Questionnaire
时间窗: 4 weeks
Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked "what one food makes it most difficult for you to control eating?" and question #10 asked " What time are you particularly vulnerable to this one food." Higher ratings are consistent with a more significant or more frequent outcome. Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order).
次要结局
- Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.(4 weeks)
- Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.(4 weeks)