NCT02091570已完成不适用
A Randomized, Controlled, Double-Blind Crossover Pilot Trial to Assess the Effects of Nutrition Bars on Subjective Ratings of Hunger and Fullness in Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- self-reported hunger and fullness rating
研究概览
简要总结
This study investigates nutrition bar consumption and possible impact on self-reported ratings of hunger and fullness compared to a control.
详细描述
Participant eligibility will be screened at visit 1. Test days will commence at 8 to 10 a.m. and visits two to four will be spaced four days apart. On visit days participants consume a nutrition bar; satiety and hunger ratings, blood samples are collected simultaneously over a three hour period. After completion, participants will complete gastrointestinal (GI) tolerability as well as Palatability and Adverse Events questionnaires.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women
- •Body mass index (BMI) 20.00-29.99 kg/m2
- •Maintenance of habitual diet, physical activity patterns, and body weight throughout the trial
- •In general good health on the basis of medical history; and taking no medication other than birth control, hormone replacement therapy, statins or blood pressure medication
- •Participant understands the study procedures, provides signed informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
- •Participant can consume a nutrition bar in the allotted time frame
排除标准
- •Use of over-the-counter weight-loss drugs and herbal remedies or supplements and dieting programs/behavior (within two months of visit 1)
- •Variation in body weight >8.8 lbs. (4 kg) within the previous three month before screening
- •Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
- •Subject scores ≥14 on restraint factor of the Three-Factor Eating Questionnaire
- •History or presence of clinically important renal or gastrointestinal disorders, or diabetes mellitus
- •Extreme dietary habits (e.g. vegan, Atkins diet, exclusion of major food groups, etc.)
- •History of allergy, sensitivity, or strong dislike towards any of the components of the study products
- •Females who are pregnant, or planning to be pregnant during the study period or lactating
- •Use of an investigational drug product within the last 30 days
- •Individual has a condition the Investigator believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
- •Subject does not understand English.
结局指标
主要结局
self-reported hunger and fullness rating
时间窗: 3 hour period after consumption of study product, on 3 occasions
change in self-reported hunger or fullness compared to placebo
次要结局
- blood sample analytes(3 hour period after consumption of study product, on 3 occasions)
研究者
研究点 (2)
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