Pasta Formulations, Portion Sizes and Their Effect on Appetite (SET)
Understanding Pasta Formulations and Portion Size on Satiety in Healthy Weight Women
Investigators are interested in learning how appetite responds to pasta containing different amounts of protein and fiber when provided in two different portion sizes.
In this research study, subjects will be asked to eat an entire pasta serving containing different amounts of protein and fiber mixtures. Subjects will be asked to do this on six separate occasions. One time subjects will not receive pasta, only water.
After the pasta serving, there will be a buffet of deli style lunch items and subjects may eat as much they desire. Thereafter subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours. In addition, blood will be taken throughout the study period to determine how eating pasta servings in different portion sizes impacts certain hormones released from the intestine, and therefore how they influence appetite. All study visits will take approximately 4 ½ - 5 hours.
研究概览
地位
详细说明
The study is a randomized, 7-arm, treatment-controlled, within-subjects, 3-hour postprandial crossover study to evaluate the satiety and metabolic effects of pasta formulations in 2 portion sizes on lunch intake in healthy weight women. The study design will test 3 varying pasta formulations (2 experimental and 1 standard control) at 2 fixed portion sizes in a preload plus test lunch setting in relatively healthy unrestrained women.
This study will require one initial screening visit (approximately 1 hour) and seven study visits each lasting approximately 5 hours. All visits should be completed within 2 months. 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 relating to eating, health, exercise and mood.
If willing and eligible to participate, subjects will have seven study visits. The pasta meal will be provided 5 hours after a standardized breakfast which is considered the usual breakfast for each subject at the same time of day on each study visit day. Upon arrival at each visit, subjects will have anthropometric measurements, vital signs and blood glucose finger prick. Thereafter, subjects will document subjective feelings of satiety followed by a blood draw. Upon completion of pre-study procedures, subjects will be asked to consume an entire pasta serving (with the exception of one visit, where no pasta will be served). Shortly thereafter, subjects will be served a buffet lunch and they may eat as desired, asking for more if desired. Throughout the study and after the lunch buffet, subjects will be followed for 3 hours assessing subjective feelings of satiety at designated time points along with blood draws measuring metabolic associated meal responses. During the course of the study, subjects will be instructed to maintain their usual level of activity and diet. Four day food records will be maintained throughout the course of the study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60616
- Clinical Nutrition Research Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Females
- 18 years of age and older
- Body mass index (BMI) 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)
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：experimental pasta B, small
small portion experimental pasta B
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experimental pasta, small portion
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实验性的：experimental pasta C, small portion
small portion experimental pasta C
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experimental pasta C, small portion
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安慰剂比较：Control pasta, small
small portion Control pasta
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control pasta, small portion
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其他：No Load
Only water
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no pasta, water only
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有源比较器：Control pasta, medium
medium portion Control pasta
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control pasta, medium portion
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实验性的：experimental pasta B, medium portion
medium portion experimental pasta B
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experimental pasta B, medium portion
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实验性的：experimental pasta C, medium portion
medium portion experimental pasta B
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experimental pasta C, medium portion
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To investigate the effect of pasta formulations and portion size incorporated into a lunch meal on satiety (inhibition of further eating) as determined by subsequent second meal intake along with subjective responses on visual analog scales
大体时间：3 hour post prandial study
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Meals will be provided 4 1/2 hours after a standardized breakfast and subjects must eat the entire pasta serving.
After the pasta serving, a buffet lunch will be served and subjects may eat as much as desired.
Immediately thereafter, subjects will record satiety responses at 0 min (immediately post consumption), 20, 40, 60, 90, 120, 150 and 180 on a visual analog scale (VAS).
The subject will answer a series of questions on the VAS at each respective time point describing their feelings of hunger, fullness and desire to eat.
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3 hour post prandial study
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To investigate the effect of pasta formulations and portion size incorporated into a lunch meal on postprandial intestinal phase mechanisms of satiety and meal-associated metabolic response patterns
大体时间：3 hour postprandial study
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Meals will be provided 4 1/2 hours after a standardized breakfast and subjects must eat the entire pasta serving.
After the pasta serving, a buffet lunch will be served and subjects may eat as much as desired.
Immediately thereafter, subjects will have blood drawn at 0 min (immediately post consumption), 20, 40, 60, 90, 120, 150 and 180.
Blood samples will be drawn for measurement of plasma lipids, glucose, insulin and gut peptide hormones (GLP-1 and PYY).
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3 hour postprandial study
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合作者和调查者
调查人员
- 首席研究员：Britt Burton-Freeman, PhD, MS、Clinical Nutrition Research Center, Illinois Institute of Technology
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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