Effect of Food Form on Satiety and Gastric Emptying
| Tracking Information | |||||
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| First Received Date ICMJE | April 12, 2010 | ||||
| Last Updated Date | March 28, 2012 | ||||
| Start Date ICMJE | May 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled. [ Time Frame: May 2010 to December 2010 ] [ Designated as safety issue: No ] Subjects will consume both liquid and solid meals and we will evaluate and compare gastric emptying time after each of them. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01102907 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled. [ Time Frame: May 2010 to December 2010 ] [ Designated as safety issue: No ] Subjects will consume both liquid and solid meals and we will evaluate and compare appetite and food intake after each of them. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Food Form on Satiety and Gastric Emptying | ||||
| Official Title ICMJE | Beverages and Obesity: Effect of Food Form on Satiety and Hunger | ||||
| Brief Summary | Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. The study population will include 10 healthy women, who have a normal body mass index. We have chosen to evaluate only women because this is a small pilot study and one of our endpoints is gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying will be evaluated using the Smartpill technology, satiety will be evaluated using computerized visual analog scales/questions, and food intake will be measured by providing subjects with an ad libitum/buffet-style lunch. Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast compared to a liquid breakfast. We also hypothesize that our subjects will have a slower gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for breakfast. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Healthy women; age 18 - 35; body mass index in the healthy range between 18.5 and 25; proficient English speakers; non-smoking; not taking medications; non-dieting (weight stable over last 3 months); able to swallow a large capsule |
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| Condition ICMJE | Appetite | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01102907 | ||||
| Other Study ID Numbers ICMJE | Food Form and Satiety | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Minnesota - Clinical and Translational Science Institute | ||||
| Study Sponsor ICMJE | University of Minnesota - Clinical and Translational Science Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Minnesota - Clinical and Translational Science Institute | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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