NCT01454219

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 15, 2012

Status Verified

November 1, 2011

Enrollment Period

5 months

First QC Date

October 14, 2011

Last Update Submit

February 14, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Glycemic index (GI)

    The 2 hours glycemic responses to bakery and confectionery products (the incremental area under the glucose response curve, IAUC).

Secondary Outcomes (2)

  • Insulin index (II)

  • Glycemic load (GL)

Interventions

Bakery and confectionary productsOTHER

Control product: Glucose solution, Test products: 11 bakery and confectionary products

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Life Sciences Ltd

Kajaani, 87100, Finland

Location

Study Officials

  • Päivi Cheney, MD

    PRINCIPAL INVESTIGATOR

  • Tiina Suutari, M.Sc.

    Clinical Life Sciences Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 15, 2012

Record last verified: 2011-11

Locations

FI(1)