Understanding the Role of Chewing Gum in Satiation, Satiety and Hunger Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- To characterize the subjective and metabolic satiety response pattern to chewing gum vs. no chewing gum on subjective satiety and subsequent second meal intake in adult women.
研究概览
简要总结
Investigators are interested in learning how appetite responds after chewing gum.
In this research study subjects will be asked to eat a lunch meal provided at our Center. After eating the lunch meal, subjects will answer questions describing their feelings of hunger, thirst and desire to eat every 30 minutes for 3 hours.
Blood will be drawn throughout the study period to determine how chewing gum impacts certain hormones released from your intestine after eating and therefore how they influence your appetite. Blood draws will be done every 30 minutes for 3 hours. At only one of the two study visits, subjects will chew gum during specific times. One study visit will not include chewing gum.
After three hours, there will be a snack to eat as much as desired followed by one more set of questions and blood draw.
All study visits will take approximately 4 ½ hours.
详细描述
The study is a randomized, 2-arm, placebo-controlled, within-subjects crossover study to evaluate the satiety and metabolic response patterns of gum/no gum in relatively healthy weight and obese women.
The study will require one initial screening visit (1 hour) and 2 study visits. We are looking for healthy, non-smoking women older than 18 years of age with no significant medical history.
The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, vital signs, blood glucose test (finger prick) and completion of a series of surveys related to eating, health, exercise and mood.
If willing and eligible to participate, subjects will have 2 study visits. The lunch will be provided 4 hours after a intra-subject standardized breakfast (the same breakfast for each subject before each study visit). Upon arrival at each visit, subjects will have anthropometric measurements, vital signs upon blood glucose finger prick as well as assessment for compliance with breakfast protocol, subsequent fasting and adequate water intake.
Upon completion of pre-study procedures, a registered nurse will place a catheter (flexible tubing) in the subjects' arm during each study visit. A catheter is used so subjects are not stuck with a needle for every blood sample. Instead, the catheter is inserted using a needle, the needle is removed and the flexible plastic tubing remains the arm for the duration of the study day serving as a port for collecting blood samples at the specific time points
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •Healthy weight: BMI between 18.5 and 24.9 kg/m2, inclusive
- •Obese: BMI between 30 - 38 kg/m2, inclusive
- •No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- •Unrestrained eater (score < 10 on the Three Factor Eating Questionnaire)
排除标准
- •Pregnant and/or lactating or planning for pregnancy
- •Allergies or intolerances to foods consumed in the study
- •Fasting blood glucose > 110 mg/dL. Subjects identified with elevated fasting blood glucose levels will be will be advised to contact their primary care physician for appropriate follow-up care.
- •Taking over the counter supplements that may interfere with the study procedures or endpoints
- •Taking prescription medications that may interfere with study procedures or endpoints (medications that affect appetite, unstable dose of hormones <6 months)
- •Subjects with unusual dietary habits (e.g. pica)
- •Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period)
- •Excessive exercisers or trained athletes
- •Addicted to drugs and/or alcohol
- •Medically documented psychiatric or neurological disturbances
- •Smoker (past smoker may be allowed if cessation is > 2 years)
结局指标
主要结局
To characterize the subjective and metabolic satiety response pattern to chewing gum vs. no chewing gum on subjective satiety and subsequent second meal intake in adult women.
时间窗: 4 hour post prandial study
Chewing gum will be provided throughout the 4 hour post-prandial study at defined intervals at one of the two study visits. Feelings of hunger, fullness and desire to eat will be measured by the subject every 30 minutes post-lunch for 3 hours. Blood draws will also be collected every 30 minutes post-lunch for 3 hours. At 3 hours, a snack tray will be provided and subject will be instructed to consume as desired. One additional sent of questions and blood draw will be completed at 4 hours post-lunch.
次要结局
- To investigate the relationship of metabolic responses to gum-induced/enhanced satiety by evaluating changes in free-living food intake in adult women(2 days)