Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup

Healthy Volunteers Clinical Trial

Official title:

Determination of the Glycemic Index and the Insulinemic Index of a Sweetener

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717912
• Other study ID #: SIRODEX 9708
• Status: Completed
• Phase: N/A
• First received: July 16, 2008
• Last updated: July 12, 2017
• Start date: July 2008
• Est. completion date: September 2008

Study information

• Verified date: July 2017
• Source: Routin SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Experimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
• Classical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
• Classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber

Locations

Country	Name	City	State
France	Biofortis	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Routin SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Index	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.; Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above	Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
Secondary	Insulinemic Index	The specific measure that will be use to determine the insulinemic responses is the change in blood insuline levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.; Sugar syrup was used as the reference food, giving it a insulinemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above	Every 48 hours (each new intervention), over a 2 hour blood glucose challenge

External Links

•   Clinical Research Organisation in Human Nutrition