Glycaemic and Insulinaemic Responses After Consumption of FOS.

NCT ID: NCT02353403

Last Updated: 2015-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Glycaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugar

Control group consuming a dairy dessert containing 35g of dextrose.

Group Type PLACEBO_COMPARATOR

Sugar

Intervention Type OTHER

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

FOS

Group consuming a dairy dessert in which 30% of the dextrose was replaced by FOS.

Group Type EXPERIMENTAL

FOS

Intervention Type OTHER

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

Interventions

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Sugar

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

Intervention Type OTHER

FOS

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syral

INDUSTRY

Sponsor Role collaborator

Institut Pasteur de Lille

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel Lecerf

MD, Endocrinologist, Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Michel Lecerf, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille

Locations

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NutrInvest - Institut Pasteur de Lille

Lille, Nord, France

Site Status

Countries

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France

Other Identifiers

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2013-A00786-39

Identifier Type: -

Identifier Source: org_study_id

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