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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:
ClinicalTrials.gov Identifier:
NCT01575509
First Posted: April 11, 2012
Last Update Posted: June 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Kiantama Oy
Suomen Sokeri Oy
Information provided by (Responsible Party):
Clinical Life Sciences Ltd.
  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: None (Open Label)
Official Title: A Clinical, Randomized, Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects

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 ]
    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 ]
    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 ]
    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
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Clinical Life Sciences Ltd.
ClinicalTrials.gov Identifier: NCT01575509     History of Changes
Other Study ID Numbers: MAVI
First Submitted: April 10, 2012
First Posted: April 11, 2012
Last Update Posted: June 15, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Pharmaceutical Solutions