Glycaemic and Insulinaemic Responses After Consumption of FOS.

Not Applicable

Completed

• Conditions: Glycaemia
• Interventions: Other: Sugar; Other: FOS

• Registration Number: NCT02352857
• Lead Sponsor: Institut Pasteur de Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-25
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-28
• Last Update Submitted: 2015-01-28
• Study First Posted: 2015-02-02
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sugar	Sugar	Control group consuming sponge cakes containing in total 24g of dextrose.
FOS	FOS	Group consuming sponge cakes in which 30% of the dextrose was replaced by FOS.

Primary Outcome Measures

Name	Time	Method
Glycaemic response	2 hours and 5 minutes	Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.

Secondary Outcome Measures

Name	Time	Method
Insulinaemic response	2 hours and 5 minutes	Blood insulin kinetics with 7 points. Analysis of the Area under the curve of insulin.
Blood glucose peak (Cmax)	One-time data (the highest one) within the 2hrs 5mins kinetics.	Peak of blood glucose during kinetics.
Blood insulin peak (Cmax)	One-time data (the highest one) within the 2hrs 5mins kinetics.	Peak of blood insulin during 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.

Trial Locations

Locations (1)

NutrInvest - Institut Pasteur de Lille; 🇫🇷 Lille, Nord, France