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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Experimental sweetener syrup; Other: Classical sweetener syrup; Other: Classical sugar 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44200
    • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Routin SA
• Investigators: Principal Investigator: Jean-Marc Cazaubiel, Doctor, Biofortis

Publications and helpful links

Helpful Links

• Clinical Research Organisation in Human Nutrition

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 17, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: glycemic index; BLOOD GLUCOSE; rates of digestion and absorption of food
• Other Study ID Numbers: SIRODEX 9708