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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
Sponsor:
Information provided by:
Routin SA
ClinicalTrials.gov Identifier:
NCT00717912
First received: July 16, 2008
Last updated: July 17, 2008
Last verified: July 2008
  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
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, see Learn About Clinical Studies.

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 July 22, 2014