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

This study has been completed.
Sponsor:
Collaborators:
Kiantama Oy
Suomen Sokeri Oy
Information provided by (Responsible Party):
Clinical Life Sciences Ltd.
ClinicalTrials.gov Identifier:
NCT01575509
First received: April 10, 2012
Last updated: June 14, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Healthy
 Other: Berry product
Other: Bread product
Other: Glucose control solution
Other: Glucose-fructose control solution

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical, Randomized, Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Clinical Life Sciences Ltd.:

Primary Outcome Measures:
  • The 2 hours glycemic responses to test products and control solutions [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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:
  • The 2 hours insulinemic responses to dried lingonberry product and corresponding control solution [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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.

  • The incremental area under glucose curve (IAUC) of bread test products [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    IAUC (mmol/l x min) is determined using the trapezoidal method for each subject and bread test product and corresponding glucose control solution.

  • Glycemic index (GI) of bread test products [ Designated as safety issue: No ]
    The GI is calculated as a percentage of the glucose IAUC values of a bread product and a glucose control solution.


Enrollment: 14
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Berry product
    Sugar infused dried lingonberry
    Other: Bread product
    Brown bread
    Other: Bread product
    Whole grain bread
    Other: Glucose control solution
    Glucose solution with a corresponding amount of carbohydrates as provided by the bread test products
    Other: Glucose-fructose control solution
    Control solution with a similar carbohydrate content as provided by the dried lingonberry test product
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575509

Locations
Finland
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
  More Information

No publications provided

Responsible Party: Clinical Life Sciences Ltd.
ClinicalTrials.gov Identifier: NCT01575509     History of Changes
Other Study ID Numbers: MAVI
Study First Received: April 10, 2012
Last Updated: June 14, 2012
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013