Glycaemic and Insulinaemic Responses After Consumption of FOS.

NCT ID: NCT02352857

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-02-28

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.

Conditions

Glycaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar

Control group consuming sponge cakes containing in total 24g of dextrose.

Group Type: PLACEBO_COMPARATOR

Sugar

Intervention Type: OTHER

100g of sponge cakes made with 24g of dextrose.

FOS

Group consuming sponge cakes in which 30% of the dextrose was replaced by FOS.

Group Type: EXPERIMENTAL

FOS

Intervention Type: OTHER

100g of sponge cakes made with 19.4g of dextrose and 9.1g of FOS.

Interventions

Sugar

100g of sponge cakes made with 24g of dextrose.

Intervention Type: OTHER

FOS

100g of sponge cakes made with 19.4g of dextrose and 9.1g of FOS.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syral

INDUSTRY

Sponsor Role: collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role: lead

Responsible Party

Jean-Michel Lecerf

MD, Endocrinologist, Nutritionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Michel LECERF, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille

Locations

NutrInvest - Institut Pasteur de Lille

Lille, Nord, France

Countries

France

Other Identifiers

2013-A00785-40

Identifier Type: -

Identifier Source: org_study_id