Glycaemic and Insulinaemic Responses After Consumption of FOS.

Study Overview
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Brief Summary
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The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.

Official Title
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Postprandial Glycaemic and Insulinaemic Responses After Consumption of Dairy Desserts Containing Fructo-oligosaccharides in Adults.

Conditions
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Glycaemia

Intervention / Treatment
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* Other: Sugar
* Other: FOS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 18.0 and 25.0 kg/m² (included) Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit Be used to have breakfast Non-smoker for at least 3 months For the female participant: not being pregnant or breastfeeding and using efficient birth control Signed the consent form Able to follow the instructions of the study Health insured Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales). Exclusion Criteria: Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not) Fasting blood cholesterol over 6.35 mmol/L Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma) Fasting blood insulin under 20 mU/L Fasting HbA1c under 7% History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not History of dietary allergies or coeliac disease History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease Somatic or psychiatric disorders Renal insufficiency (kidney failure) SGOT or ALAT over 52.5 U/L Smoker Consuming more than 3 alcoholic beverage a day Weight varied 3 kg the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar<br>Control group consuming a dairy dessert containing 35g of dextrose. | Other: Sugar<br>* A 210g chocolate dairy dessert made with 35g of dextrose.<br>|
| Experimental: FOS<br>Group consuming a dairy dessert in which 30% of the dextrose was replaced by FOS. | Other: FOS<br>* A 210g chocolate dairy dessert made with 24g of dextrose and 11.2g of FOS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic response | Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose. | 2 hours and 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulinaemic response | Blood insulin kinetics with 7 points. Analysis of the Area under the curve of insulin. | 2 hours and 5 minutes | 
| Blood glucose peak (Cmax) | Peak of blood glucose during kinetics. | One-time data (the highest one) within the 2hrs 5mins kinetics. | 
| Blood insulin peak (Cmax) | Peak of blood insulin during kinetics. | One-time data (the highest one) within the 2hrs 5mins kinetics. | 
| Glucose Tmax : time to reach the peak of blood glucose |  | One time within the 2hrs 5mins kinetics. | 
| Insulin Tmax : time to reach the peak of blood insulin |  | One time within the 2hrs 5mins kinetics. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fructo-oligosaccharides, Sugar-reduced foods, Postprandial glucose response