Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Routin SA.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Routin SA
Information provided by:
Routin SA
ClinicalTrials.gov Identifier:
NCT00717912
First received: July 16, 2008
Last updated: July 17, 2008
Last verified: July 2008
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Purpose
The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup
| Condition | Intervention |
|---|---|
|
Healthy Volunteers |
Other: experimental sweetener syrup 1 Other: classical sugar syrup Other: experimental sweetener syrup 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Determination of the Glycemic Index and the Insulinemic Index of a Sweetener |
Resource links provided by NLM:
Further study details as provided by Routin SA:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 6 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Experimental sweetener syrup 1
|
Other: experimental sweetener syrup 1
3 glucose and insulin responses with experimental sweetener syrup 1 : 50 grams of digestible carbohydrate plus fiber
Other Name: ROUTIN sweetener syrup
|
|
Active Comparator: 2
Classical sugar syrup
|
Other: classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate
Other Name: ROUTIN classical sugar syrup
|
|
Active Comparator: 3
Experimental sweetener syrup 2
|
Other: experimental sweetener syrup 2
1 glucose and insulin responses with experimental sweetener syrup 2 : 50 grams of digestible carbohydrate plus fiber
Other Name: TEISSEIRE sweetener syrup
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- age 18-50 years
- male
- healthy volunteers
- BMI above 25 kg/m²
Exclusion Criteria:
- no medical history of hypercholesterolemia, high pressure blood, diabetes, sugar intolerance
- food allergy
- kidney deficiency
- liver troubles
- gastro-intestinal troubles
- drugs which impair sugar and lipid metabolism
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717912
Contacts
| Contact: Jean-Marc Cazaubiel, Doctor | 02 40 20 57 99 | frederic.valenti@biofortis.fr |
Locations
| France | |
| Biofortis | Recruiting |
| Nantes, France, 44200 | |
| Contact: Frédéric Valenti, CRA 02 40 20 57 99 ext 33 frederic.valenti@biofortis.fr | |
| Contact: Béatrice Baril, Manager 02 40 20 57 99 ext 33 beatrice.baril@biofortis.fr | |
| Principal Investigator: Jean-Marc Cazaubiel, Doctor | |
Sponsors and Collaborators
Routin SA
Investigators
| Principal Investigator: | Jean-Marc Cazaubiel, Doctor | BioFortis |
More Information
Additional Information:
No publications provided
| Responsible Party: | M Jean Marc Cazaubiel, BIOFORTIS |
| ClinicalTrials.gov Identifier: | NCT00717912 History of Changes |
| Other Study ID Numbers: | SIRODEX 9708 |
| Study First Received: | July 16, 2008 |
| Last Updated: | July 17, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Routin SA:
|
BLOOD GLUCOSE glycemic index rates of digestion and absorption of food |
ClinicalTrials.gov processed this record on June 18, 2013