NCT01575509

Brief Summary

This study aims to determine the 2 hour glycemic responses of two bread products and one dried lingonberry product. The average postprandial response of each product is compared with glycemic response after ingestion of control solution with a similar carbohydrate content (glucose, glucose-fructose) as the provided by the respective test product.

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 Mar 2012

Shorter than P25 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 15, 2012

Status Verified

April 1, 2012

Enrollment Period

3 months

First QC Date

April 10, 2012

Last Update Submit

June 14, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The 2 hours glycemic responses to test products and control solutions

    Capillary blood samples are taken before and at 15, 30, 45, 60, 90 and 120 min after starting to eat the test products or control solutions for measurements of plasma glucose concentrations.

    2 hours

Secondary Outcomes (3)

  • The 2 hours insulinemic responses to dried lingonberry product and corresponding control solution

    2 hours

  • The incremental area under glucose curve (IAUC) of bread test products

    2 hours

  • Glycemic index (GI) of bread test products

Interventions

Berry productOTHER

Sugar infused dried lingonberry

Bread productOTHER

Brown bread

Glucose control solutionOTHER

Glucose solution with a corresponding amount of carbohydrates as provided by the bread test products

Glucose-fructose control solutionOTHER

Control solution with a similar carbohydrate content as provided by the dried lingonberry test product

Eligibility Criteria

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

You may qualify if:

  • voluntary given written concent for participation in research
  • healthy man or woman, age between 18 and 65 years
  • regular eating
  • Body Mass Index 18,5 - 29,9 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

Study Design

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

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 11, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 15, 2012

Record last verified: 2012-04

Locations

FI(1)