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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717912
First Posted: July 18, 2008
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Routin SA
  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 Other: Classical sweetener syrup Other: Classical sugar syrup

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determination of the Glycemic Index and the Insulinemic Index of a Sweetener

Further study details as provided by Routin SA:

Primary Outcome Measures:
  • Glycemic Index [ Time Frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge ]

    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



Secondary Outcome Measures:
  • Insulinemic Index [ Time Frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge ]

    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



Enrollment: 6
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup
Other: Experimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
Experimental: Arm 2
Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup
Other: Experimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
Experimental: Arm 3
Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup
Other: Experimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
Experimental: Arm 4
Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup
Other: Experimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
Experimental: Arm 5
Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup
Other: Experimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber
Experimental: Arm 6
Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup
Other: Experimental sweetener syrup
3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sweetener syrup
1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber
Other: Classical sugar syrup
3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717912


Locations
France
Biofortis
Nantes, France, 44200
Sponsors and Collaborators
Routin SA
Investigators
Principal Investigator: Jean-Marc Cazaubiel, Doctor BioFortis
  More Information

Additional Information:
Responsible Party: Routin SA
ClinicalTrials.gov Identifier: NCT00717912     History of Changes
Other Study ID Numbers: SIRODEX 9708
First Submitted: July 16, 2008
First Posted: July 18, 2008
Results First Submitted: November 29, 2012
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Routin SA:
BLOOD GLUCOSE
glycemic index
rates of digestion and absorption of food