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

NCT00717912 | Completed Results DMC

• 1 other identifier: SIRODEX 9708
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

BLOOD GLUCOSE; glycemic index; rates of digestion and absorption of food

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Insulinemic Index

  Every 48 hours (each new intervention), over a 2 hour blood glucose challenge

Study Arms (6)

Arm 1

EXPERIMENTAL

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; Other: Classical sweetener syrup; Other: Classical sugar syrup

Arm 2

EXPERIMENTAL

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; Other: Classical sweetener syrup; Other: Classical sugar syrup

Arm 3

EXPERIMENTAL

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; Other: Classical sweetener syrup; Other: Classical sugar syrup

Arm 4

EXPERIMENTAL

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; Other: Classical sweetener syrup; Other: Classical sugar syrup

Arm 5

EXPERIMENTAL

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; Other: Classical sweetener syrup; Other: Classical sugar syrup

Arm 6

EXPERIMENTAL

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; Other: Classical sweetener syrup; Other: Classical sugar syrup

Interventions

Experimental sweetener syrup OTHER

3 glucose and insulin responses with experimental sweetener syrup : 50 grams of digestible carbohydrate plus fiber

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Classical sweetener syrup OTHER

1 glucose and insulin responses with classical sweetener syrup : 50 grams of digestible carbohydrate plus fiber

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Classical sugar syrup OTHER

3 glucose and insulin responses with classical sugar syrup : 50 grams of digestible carbohydrate plus fiber

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-50 years
• male
• healthy volunteers
• BMI above 25 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• Routin SA: lead

Study Sites (1)

Biofortis

Nantes, 44200, France

Location

Related Links

• Clinical Research Organisation in Human Nutrition

Results Point of Contact

• Title: Doctor
• Organization: Biofortis

info@mxns.com

0240205799

Study Officials

• Jean-Marc Cazaubiel, Doctor

  BioFortis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 13, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-07

Locations

FR (1)