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Completed

NCT Number: NCT02353403

Glycaemic and Insulinaemic Responses After Consumption of FOS.

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugar

Other

A 210g chocolate dairy dessert made with 35g of dextrose.

FOS

Other

A 210g chocolate dairy dessert made with 24g of dextrose and 11.2g of FOS.

Primary outcomes

  1. Glycaemic response

    Time frame: 2 hours and 5 minutes

    Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.

Secondary outcomes

  1. Insulinaemic response

    Time frame: 2 hours and 5 minutes

    Blood insulin kinetics with 7 points. Analysis of the Area under the curve of insulin.

  2. Blood glucose peak (Cmax)

    Time frame: One-time data (the highest one) within the 2hrs 5mins kinetics.

    Peak of blood glucose during kinetics.

  3. Blood insulin peak (Cmax)

    Time frame: One-time data (the highest one) within the 2hrs 5mins kinetics.

    Peak of blood insulin during kinetics.

  4. Glucose Tmax : time to reach the peak of blood glucose

    Time frame: One time within the 2hrs 5mins kinetics.

  5. Insulin Tmax : time to reach the peak of blood insulin

    Time frame: One time within the 2hrs 5mins kinetics.

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Collaborators

  • Syral

Registry information

Official study title

Postprandial Glycaemic and Insulinaemic Responses After Consumption of Dairy Desserts Containing Fructo-oligosaccharides in Adults.

Acronym: GLYCOFOS-cream

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 2, 2015
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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