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

CRITT Bio-Industries

Status

Unknown

Conditions

Healthy

Treatments

Other: Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrup

Study type

Interventional

Funder types

Other

Identifiers

NCT01343797

IGNUT PEC10513

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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