Understanding Resistant Starch on Satiety in Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake.
研究概览
简要总结
Investigators are interested in learning how appetite responds to certain types of starch and fiber mixtures. In this research study, subjects will be asked to consume cookie bars containing different types of starch and fiber mixtures, then describe their feelings of hunger, fullness and desire to eat for the 3 hour study period. Subjects will be asked to do this on four separate occasions. Following the 3 hour study period, a deli-style lunch will be served. Investigators want to see how appetite responds to these four different starch and fiber mixtures.
详细描述
This study will require one initial screening visit (approximately 1 hour) and four study visits each lasting approximately 4 hours. All visits should be done in 2 months. We are looking for healthy, non-smoking, premenopausal female volunteers older than 18 with no medical history of diabetics, heart, lung, kidney, stomach, or liver disease.
The initial screening visit will determine subject eligibility through height, weight and waist circumference measurements, blood glucose finger prick and eating, health and mood surveys.
If willing and eligible to participate, subjects will have four study visits. All study visits will be scheduled according to each individual subject's menstrual cycle. At each visit subject will be asked to eat the cookie bar and then answer questions about their feelings of hunger, fullness and desire to eat. Subject will continue to answer questions about their feelings of hunger, fullness and desire to eat at specific time points up to 3 hours after eating the yogurt. After 3 hours a lunch meal will be served. The lunch meal consists of typical deli items, such as pasta, rolls, salad, etc. Subject will be allowed to eat as much or as little of the lunch as they'd like.
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
- Single (Participant)
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
- •Premenopausal females
- •18 years of age and older
- •BMI (body mass index) between 18.5 and 24.9 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 fiber supplements or other 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)
- •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
Subjective and behavioral satiety responses after consumption of the resistant starch composites by visual analog scales and subsequent food intake.
时间窗: 3 hour postprandial study
Meals will be provided under fasting conditions and thereafter subjects will record satiety reponses at 30 mins, 60, 90, 120, 150 and 180 on a visual analog scale (VAS). The subject will answer a series of questions on the VAS describing their feelings of hunger, fullness and desire to eat at the above mentioned time points. Satiety will also be determined on the quantity of the test lunch meal consumed. This test meal will be served three hours after consumption of the starch composites.
次要结局
未报告次要终点