Glycaemic and Insulinaemic Responses After Consumption of FOS.

Glycaemia Clinical Trial

— GLYCOFOS-cake  

Official title:

Postprandial Glycaemic and Insulinaemic Responses After Consumption of Minicakes Containing FOS in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352857
• Other study ID #: 2013-A00785-40
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: January 28, 2015
• Start date: October 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Institut Pasteur de Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Glycaemia

Intervention

Other:
• Sugar
100g of sponge cakes made with 24g of dextrose.
• FOS
100g of sponge cakes made with 19.4g of dextrose and 9.1g of FOS.

Locations

Country	Name	City	State
France	NutrInvest - Institut Pasteur de Lille	Lille	Nord

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur de Lille	Syral

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic response	Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.	2 hours and 5 minutes	No
Secondary	Insulinaemic response	Blood insulin kinetics with 7 points. Analysis of the Area under the curve of insulin.	2 hours and 5 minutes	No
Secondary	Blood glucose peak (Cmax)	Peak of blood glucose during kinetics.	One-time data (the highest one) within the 2hrs 5mins kinetics.	No
Secondary	Blood insulin peak (Cmax)	Peak of blood insulin during kinetics.	One-time data (the highest one) within the 2hrs 5mins kinetics.	No
Secondary	Glucose Tmax : time to reach the peak of blood glucose		One time within the 2hrs 5mins kinetics.	No
Secondary	Insulin Tmax : time to reach the peak of blood insulin		One time within the 2hrs 5mins kinetics.	No