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

A Clinical, Randomized, 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Berry product; Other: Bread product; Other: Bread product; Other: Glucose control solution; Other: Glucose-fructose control solution

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kajaani, Finland, 87100
    • Clinical Life Sciences Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 2 hours glycemic responses to test products and control solutions	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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 2 hours insulinemic responses to dried lingonberry product and corresponding control solution	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 hours
The incremental area under glucose curve (IAUC) of bread test products	IAUC (mmol/l x min) is determined using the trapezoidal method for each subject and bread test product and corresponding glucose control solution.	2 hours
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.

Collaborators and Investigators

• Sponsor: Clinical Life Sciences Ltd.
• Collaborators: Kiantama Oy; Suomen Sokeri Oy
• Investigators: Principal Investigator: Päivi Cheney, MD

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 10, 2012
• First Posted (Estimate): April 11, 2012

Study Record Updates

• Last Update Posted (Estimate): June 15, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: MAVI