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

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ClinicalTrials.gov Identifier: NCT01575509
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : June 15, 2012
Sponsor:
Collaborators:
Kiantama Oy
Suomen Sokeri Oy
Information provided by (Responsible Party):
Clinical Life Sciences Ltd.

Study Description
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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
Healthy Other: Berry product Other: Bread product Other: Glucose control solution Other: Glucose-fructose control solution Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Arms and Interventions
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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

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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Finland
Clinical Life Sciences Ltd
Kajaani, Finland, 87100
Sponsors and Collaborators
Clinical Life Sciences Ltd.
Kiantama Oy
Suomen Sokeri Oy
Investigators
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Principal Investigator: Päivi Cheney, MD
More Information
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Responsible Party: Clinical Life Sciences Ltd.
ClinicalTrials.gov Identifier: NCT01575509    
Other Study ID Numbers: MAVI
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Pharmaceutical Solutions