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A Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects

Sponsor
Clinical Life Sciences Ltd. (Other)
Overall Status
Completed
CT.gov ID
NCT01575509
Collaborator
Kiantama Oy (Industry), Suomen Sokeri Oy (Other)
14
Enrollment
1
Location
3
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Berry product
  • Other: Bread product
  • Other: Bread product
  • Other: Glucose control solution
  • Other: Glucose-fructose control solution
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Clinical, Randomized, Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Outcome Measures

Primary Outcome Measures

  1. The 2 hours glycemic responses to test products and control solutions [2 hours]

    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.

Secondary Outcome Measures

  1. The 2 hours insulinemic responses to dried lingonberry product and corresponding control solution [2 hours]

    Capillary blood samples are collected before and at 15, 30, 45, 60, 90 and 120 min after eating the lingonberry test product and glucose-fructose control solution. The serum insulin concentrations are analysed.

  2. The incremental area under glucose curve (IAUC) of bread test products [2 hours]

    IAUC (mmol/l x min) is determined using the trapezoidal method for each subject and bread test product and corresponding glucose control solution.

  3. Glycemic index (GI) of bread test products []

    The GI is calculated as a percentage of the glucose IAUC values of a bread product and a glucose control solution.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • diabetes

  • gastrointestinal diseases

  • hepatic, kidney, pancreas or thyroid disease or disorder

  • arthritis

  • pregnancy or breast feeding

  • smoking

  • allergy

  • severe diseases

  • blood donation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Life Sciences Ltd Kajaani Finland 87100

Sponsors and Collaborators

  • Clinical Life Sciences Ltd.
  • Kiantama Oy
  • Suomen Sokeri Oy

Investigators

  • Principal Investigator: Päivi Cheney, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinical Life Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT01575509
Other Study ID Numbers:
  • MAVI
First Posted:
Apr 11, 2012
Last Update Posted:
Jun 15, 2012
Last Verified:
Apr 1, 2012
Additional relevant MeSH terms:
Pharmaceutical Solutions

Study Results

No Results Posted as of Jun 15, 2012