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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT01575509
• Lead Sponsor: Clinical Life Sciences Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The 2 hours glycemic responses to test products and control solutions	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

Name	Time	Method
The 2 hours insulinemic responses to dried lingonberry product and corresponding control solution	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	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.

Trial Locations

Locations (1)

Clinical Life Sciences Ltd; 🇫🇮 Kajaani, Finland