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NCT Number: NCT01575509

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Life Sciences Ltd

Kajaani, 87100, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Berry product

Other

Sugar infused dried lingonberry

Bread product

Other

Brown bread

Glucose control solution

Other

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

Glucose-fructose control solution

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Clinical Life Sciences Ltd.

Other

Collaborators

  • Kiantama Oy
  • Suomen Sokeri Oy

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2012
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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