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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
July 16, 2008
July 18, 2008
November 29, 2012
July 13, 2017
July 13, 2017
July 2008
September 2008   (Final data collection date for primary outcome measure)
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

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 ]
Complete list of historical versions of study NCT00717912 on ClinicalTrials.gov Archive Site
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

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 ]
Not Provided
Not Provided
 
Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup
Determination of the Glycemic Index and the Insulinemic Index of a Sweetener
The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
  • 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 1
    Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup
    Interventions:
    • Other: Experimental sweetener syrup
    • Other: Classical sweetener syrup
    • Other: Classical sugar syrup
  • Experimental: Arm 2
    Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup
    Interventions:
    • Other: Experimental sweetener syrup
    • Other: Classical sweetener syrup
    • Other: Classical sugar syrup
  • Experimental: Arm 3
    Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup
    Interventions:
    • Other: Experimental sweetener syrup
    • Other: Classical sweetener syrup
    • Other: Classical sugar syrup
  • Experimental: Arm 4
    Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup
    Interventions:
    • Other: Experimental sweetener syrup
    • Other: Classical sweetener syrup
    • Other: Classical sugar syrup
  • Experimental: Arm 5
    Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup
    Interventions:
    • Other: Experimental sweetener syrup
    • Other: Classical sweetener syrup
    • Other: Classical sugar syrup
  • Experimental: Arm 6
    Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup
    Interventions:
    • Other: Experimental sweetener syrup
    • Other: Classical sweetener syrup
    • Other: Classical sugar syrup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00717912
SIRODEX 9708
Yes
Not Provided
Not Provided
Routin SA
Routin SA
Not Provided
Principal Investigator: Jean-Marc Cazaubiel, Doctor BioFortis
Routin SA
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP