The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake
| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 14, 2012 |
| Last Updated Date | May 24, 2013 |
| Start Date ICMJE | August 2012 |
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Satiety Impact [ Time Frame: Baseline to 2 days ] [ Designated as safety issue: No ] Breakfast containing 250 kcal of Oat-based breakfast cereal will cause people to eat less at lunch compared to a breakfast containing 250 kcal of the ready-to-eat oat-based breakfast cereal. Area under the curve (AUC) of appetite and satiety. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01666574 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Impact on food intake at lunch [ Time Frame: Baseline to 2 days ] [ Designated as safety issue: No ] You will fill out a visual analog scales at 30, 60, 120, 180, and 240 minutes following the start of the breakfast meal each day. Four hours after the start of breakfast, you will be presented with a lunch and will be asked to eat to your satisfaction over 20 minutes. You will be asked how you are feeling periodically throughout the test. Area under the curve for subjective energy measures |
| 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 | The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake |
| Official Title ICMJE | The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake. |
| Brief Summary | This study is to determine if two breakfasts of equivalent calories, an oat based breakfast cereal or a ready-to-eat cereal, provide the same satiety benefits. The study will also determine if the two calorically equivalent oat-based breakfast cereals give different caloric intakes at a lunch meal that participants will eat to their satisfaction. |
| Detailed Description | The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older will be enrolled to investigate the satiety and food intake at lunch after a breakfast consisting of one of two randomly assigned oat-based cereals and milk breakfast. Visual analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120, 180, and 240 minutes following consumption. Subjects will be asked to eat Lunch until satisfied. The subjects will have the two breakfasts in a balanced and random order and the two meal tests will be separated by at least a week. |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (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 | Active, not recruiting |
| Estimated Enrollment ICMJE | 48 |
| Estimated Completion Date | December 2013 |
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| 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 | NCT01666574 |
| Other Study ID Numbers ICMJE | PBRC12029 (Period 2) |
| Has Data Monitoring Committee | No |
| Responsible Party | Frank Greenway, Pennington Biomedical Research Center |
| Study Sponsor ICMJE | Pennington Biomedical Research Center |
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided |
| Information Provided By | Pennington Biomedical Research Center |
| Verification Date | May 2013 |
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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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