Glycaemic and Insulinaemic Responses After Consumption of... | NCT02353403

Studies
Glycaemic and Insulinaemic Responses After Consumption of FOS.

NCT02353403

Sponsor

Institut Pasteur de Lille

Status

Completed

Last Update Posted

Feb 2, 2015Estimated

Enrollment

27Actual

Phase

Not Applicable

Conditions

Glycaemia

Interventions

Sugar
FOS

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jan 28, 2015

First Submission Date that Met QC Criteria

Jan 30, 2015

First Posted Date

Feb 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2015

Last Update Posted Date

Feb 2, 2015Estimated

Name	Class
Syral	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sugar	Placebo Comparator	Control group consuming a dairy dessert containing 35g of dextrose.	Other: Sugar
FOS	Experimental	Group consuming a dairy dessert in which 30% of the dextrose was replaced by FOS.	Other: FOS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugar	Other	A 210g chocolate dairy dessert made with 35g of dextrose.	Sugar

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided