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

P

Pasteur Institute of Lille (IPL)

Status

Completed

Conditions

Glycaemia

Treatments

Other: Sugar
Other: FOS

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02353403
2013-A00786-39

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

27 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

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

27 participants in 2 patient groups, including a placebo group

Sugar
Placebo Comparator group
Description:
Control group consuming a dairy dessert containing 35g of dextrose.
Treatment:
Other: Sugar
FOS
Experimental group
Description:
Group consuming a dairy dessert 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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