Appetite Clinical Trial
— SATOfficial title:
Understanding Pasta Formulations on Satiation in Healthy Weight Women
Verified date | July 2021 |
Source | Clinical Nutrition Research Center, Illinois Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators are interested in learning how appetite responds to pasta containing different amounts of protein and fiber. In this research study, subjects will be asked to eat as much as they want of pasta containing different amounts of protein and fiber mixtures, thereafter subjects will describe their feelings of hunger, fullness and desire to eat for 3 hours afterwards. Subjects will be asked to do this on three separate occasions.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 19, 2018 |
Est. primary completion date | December 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Nutrition Research Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Center, Illinois Institute of Technology | Barilla America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate the effect of pasta formulations incorporated into a lunch meal on satiation (meal termination) as determined by energy intake of the meal along with subjective responses on visual analog scales and subsequent food intake. | Meals will be provided 4 1/2 hours after a standardized breakfast (subject's own usual breakfast in the same quantity at the same time before each study visit) and subjects will be able to eat as much of the pasta as they would like and may request more if 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. | 3 hour post prandial study |
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