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Glycemic and Insulinemic Index Determination of Two Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix (IGNUT)

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ClinicalTrials.gov Identifier: NCT01343797
Recruitment Status : Unknown
Verified April 2011 by CRITT Bio-Industries.
Recruitment status was:  Active, not recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
Sponsor:
Collaborators:
BioFortis
NUTRITIS
Information provided by:
CRITT Bio-Industries

Tracking Information
First Submitted Date  ICMJE April 20, 2011
First Posted Date  ICMJE April 28, 2011
Last Update Posted Date April 28, 2011
Study Start Date  ICMJE February 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Area Under the glycemia Curve over 120 min (AUC 0-120min) [ Time Frame: 120 minutes after intake by test ]
Syrup glycemic response compare to glucose glycemic response. Measure with glucometer at time 15, 30, 45, 60, 90, 120 (and 180 minutes) after the intake of 50g of glucose equivalent from the products (syrup or glucose). AUC(0-120min) calculation is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
Area Under the insulinemia Curve over 120 min (AUC 0-120min) [ Time Frame: 120 minutes after intake by test ]
Syrup insulinemia response compare to glucose insulinemia response. Measure at time 15, 30, 45, 60, 90, 120 (and 180 minutes) after the intake of 50g of glucose equivalent from the products (syrup or glucose). AUC(0-120min) calculation is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glycemic and Insulinemic Index Determination of Two Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix
Official Title  ICMJE Glycemic and Insulinemic Index Determination of 2 Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix
Brief Summary The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups : FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.
Detailed Description

12 male and female healthy adults are included in the study. During 5 separated visits subjects consume either 50 g of glucose in water (3 glucose response tests) or portion of syrup supply the equivalent of 50 g of glycaemic carbohydrates (2 syrup response tests).

Experimental sessions last 3 hours with 9 veinous and capillary blood taking. The experimental meals are served at t0 and are consumed between 12 and 15 minutes maximum. At time -5, 0, 15, 30, 45, 60, 90, 120 and 180 minutes, glucose is measured out on capillary blood and insulin is measured out on venous blood.

The glycemic index and Insulinemic index determination of the 2 syrups start by the calculation for each glycemia and insulinemia responses of the AUC over 120 min. The AUC(0-120min) is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration. then GI and II values expressed in percentage are calculated by dividing the AUC(0-120min) for test syrup products by the AUC(0-120min) for the glucose reference and multiplying by 100.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Other: Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrup
One test with 65,5g of fruit (apple) extract sugar syrup with high fructose content in 250mL of water One test with 108,2g of peach purified sugar syrup with high fructo-oligosaccharid content in 250mL of water Three tests with the reference : 50g of anhydrous glucose in 250mL of water
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April 27, 2011)
12
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 18 to 50 years (limits included
  • With a BMI between 19 and 25 kg/m² (limits included)
  • Non-smoker
  • Non-menopausal female with reliable contraception for two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
  • Capable and willing to conform to the protocol and accepting to give his written informed consent
  • Registered to Social Security System
  • Accepting to be registered on the Volunteers in biomedical research file

After biological analysis, the subjects will be included on the following criteria :

  • Fasting blood sugar level < 1,1 g/L
  • Blood sugar level 120 minutes after 75g glucose intake < 1.4 g/L
  • Complete blood count without significant clinically abnormality according to the investigator
  • ASAT < 1,55 µkat/L
  • ALAT < 1,7 µkat/L
  • GGT < 2,55 µkat/L
  • 45 < Creatinine < 104 µmol/L
  • 1.7 < Urea < 8.3 mmol/L

Exclusion Criteria:

  • Known food allergy, in particular to one of the tested products' components or to related products
  • Personal history of hypercholesterolemia, high blood pressure, diabetes or glucose intolerance
  • Renal insufficiency
  • Liver disorders ongoing
  • Gastrointestinal disorders, clinically significant according the investigator
  • Use of medications which could affect lipidic or carbohydrate metabolism
  • Disease or medication with impact on nutrients digestion and absorption
  • Pregnant or breastfeeding women
  • General anaesthetic in the month before the study
  • Presenting a psychological or linguistic incapability to sign the informed consent
  • Refusing to sign the informed consent
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
  • Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
  • Impossible to contact in case of emergency
  • Major or medical or surgical event with hospitalization in the last 3 months
  • Taking part in an-other clinical trial or being in the exclusion period of a previous clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01343797
Other Study ID Numbers  ICMJE IGNUT PEC10513
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Françoise OUARNE, CRITT Bio-Industries
Study Sponsor  ICMJE CRITT Bio-Industries
Collaborators  ICMJE
  • BioFortis
  • NUTRITIS
Investigators  ICMJE Not Provided
PRS Account CRITT Bio-Industries
Verification Date April 2011

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