Glycaemic and Insulinaemic Responses After Consumption of FOS. (GLYCOFOS-cake)

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

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.

Study Overview

• Status: Completed
• Conditions: Glycaemia
• Intervention / Treatment: Other: Sugar; Other: FOS

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59019
      • NutrInvest - Institut Pasteur de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille
• Collaborators: Syral
• Investigators: Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): February 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 28, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Fructo-oligosaccharides; Sugar-reduced foods; Postprandial glucose response
• Other Study ID Numbers: 2013-A00785-40