Measurement of Glycaemic Responses of Bakery and Confecti... | NCT01454219

Studies
Measurement of Glycaemic Responses of Bakery and Confectionery Products

NCT01454219

Sponsor

Clinical Life Sciences Ltd.

Status

Completed

Last Update Posted

Feb 15, 2012Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Bakery and confectionary products

Countries

Finland

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

Nov 2011

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

Aug 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Oct 14, 2011

First Submission Date that Met QC Criteria

Oct 14, 2011

First Posted Date

Oct 18, 2011Estimated

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

Feb 14, 2012

Last Update Posted Date

Feb 15, 2012Estimated

Name	Class
Fazer	OTHER

Description Module

Brief Summary

This study aims to determine the glycemic index, glycemic load and insulin index of eleven Fazer bakery and confectionary products.

Detailed Description

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

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bakery and confectionary products	Other	Control product: Glucose solution, Test products: 11 bakery and confectionary products

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic index (GI)	The 2 hours glycemic responses to bakery and confectionery products (the incremental area under the glucose response curve, IAUC).

Secondary Outcomes

Measure	Description	Time Frame
Insulin index (II)	The 2 hours insulinemic responses to bakery and confectionery products (the incremental area under the insulin response curve, IAUC).
Glycemic load (GL)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

voluntarily given written consent for participation in research
healthy man or women, age between 18 ang 65 years
regular eating
Body Mass Index 18,5 - 24,9 kg/m2

Exclusion Criteria:

diabetes
gastrointestinal diseases
hepatic, kidney, pancreas or thyroid disease or disorder
arthritis
pregnancy or breast feeding
smoking
allergy
severe diseases
blood donation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Päivi Cheney, MD		Principal Investigator
Tiina Suutari, M.Sc.	Clinical Life Sciences Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Life Sciences Ltd		Kajaani		87100	Finland