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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575509
• Other study ID #: MAVI
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: June 14, 2012
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: April 2012
• Source: Clinical Life Sciences Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Berry product
Sugar infused dried lingonberry
• Bread product
Brown bread
• Bread product
Whole grain bread
• Glucose control solution
Glucose solution with a corresponding amount of carbohydrates as provided by the bread test products
• Glucose-fructose control solution
Control solution with a similar carbohydrate content as provided by the dried lingonberry test product

Locations

Country	Name	City	State
Finland	Clinical Life Sciences Ltd	Kajaani

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Life Sciences Ltd.	Kiantama Oy, Suomen Sokeri Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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.		No