Pasta Formulations, Portion Sizes and Their Effect on Appetite
NCT ID: NCT01199770
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2010-09-15
2011-11-18
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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experimental pasta B, small
small portion experimental pasta B
Experimental B, small
experimental pasta, small portion
experimental pasta C, small portion
small portion experimental pasta C
Experimental pasta C, small
experimental pasta C, small portion
Control pasta, small
small portion Control pasta
Control, small
control pasta, small portion
No Load
Only water
NL
no pasta, water only
Control pasta, medium
medium portion Control pasta
control, medium
control pasta, medium portion
experimental pasta B, medium portion
medium portion experimental pasta B
experimental pasta B, medium
experimental pasta B, medium portion
experimental pasta C, medium portion
medium portion experimental pasta B
experimental pasta C, medium
experimental pasta C, medium portion
Interventions
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Control, small
control pasta, small portion
Experimental B, small
experimental pasta, small portion
Experimental pasta C, small
experimental pasta C, small portion
control, medium
control pasta, medium portion
experimental pasta B, medium
experimental pasta B, medium portion
experimental pasta C, medium
experimental pasta C, medium portion
NL
no pasta, water only
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
Yes
Sponsors
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Barilla America, Inc.
INDUSTRY
Clinical Nutrition Research Center, Illinois Institute of Technology
INDUSTRY
Responsible Party
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Principal Investigators
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Britt Burton-Freeman, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
Clinical Nutrition Research Center, Illinois Institute of Technology
Indika Edirisinghe, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Nutrition Research Center, Illinois Institute of Technology
Locations
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Clinical Nutrition Research Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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SET 2010-043
Identifier Type: -
Identifier Source: org_study_id
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