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

P

Pasteur Institute of Lille (IPL)

Status

Completed

Conditions

Glycaemia

Treatments

Other: Sugar
Other: FOS

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02352857
2013-A00785-40

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups, including a placebo group

Sugar
Placebo Comparator group
Description:
Control group consuming sponge cakes containing in total 24g of dextrose.
Treatment:
Other: Sugar
FOS
Experimental group
Description:
Group consuming sponge cakes in which 30% of the dextrose was replaced by FOS.
Treatment:
Other: FOS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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