Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | July 16, 2008 | ||||
| Last Updated Date | July 17, 2008 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00717912 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The specific measure that will be use to determine the insulinemic responses is the change in blood insulin levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ] | ||||
| 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 | Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup | ||||
| Official Title ICMJE | Determination of the Glycemic Index and the Insulinemic Index of a Sweetener | ||||
| Brief Summary | The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup |
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| Detailed Description | Glycemic index is a measure of how carbohydrate-containing foods affect blood glucose levels. All foods that contain carbohydrates, such as starchy vegetables (potatoes, corn), desserts, fruits, bread, pasta, and rice, can be tested for how they affect blood sugar levels after being eaten. Glycemic index is assessed by having one or more people eat a specific amount of a single food (usually 50 grams of digestible carbohydrate) and then measuring the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate, such as white bread or glucose. The average change in blood sugar levels over a set period of time relative to the levels after consumption of the control food, usually white bread or glucose, is the food's glycemic index. Insulinemic index is measure with the same methodology. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy Volunteers | ||||
| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 6 | ||||
| Estimated Completion Date | September 2008 | ||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00717912 | ||||
| Other Study ID Numbers ICMJE | SIRODEX 9708 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | M Jean Marc Cazaubiel, BIOFORTIS | ||||
| Study Sponsor ICMJE | Routin SA | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Routin SA | ||||
| Verification Date | July 2008 | ||||
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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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