Understanding Resistant Starch on Satiety in Premenopausal Women
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| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60616 |
| Conditions: |
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Psychological Phenomena and Processes |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- 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)
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)
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| NCT ID: |
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NCT01125878 |
| Primary Contact: |
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Principal Investigator
Britt Burton-Freeman, PhD, MS
Institute for Food Safety and Health, United States
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chicago, Illinois 60616
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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