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 Minicakes Containing FOS 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar<br>Control group consuming sponge cakes containing in total 24g of dextrose. | Other: Sugar<br>* 100g of sponge cakes made with 24g of dextrose.<br>|
| Experimental: FOS<br>Group consuming sponge cakes in which 30% of the dextrose was replaced by FOS. | Other: FOS<br>* 100g of sponge cakes made with 19.4g of dextrose and 9.1g 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