The Glycemic and Insulinemic Responses Elicited by Meals Containing Whole Grain Rye Bread or White Wheat Bread

September 3, 2015 updated by: Mikael Fogelholm, University of Helsinki

The Effects of Margarine and Ham or Vegetable Soup on the on the Glycemic and Insulinemic Responses Elicited by Whole Grain Rye Bread or White Wheat Bread

This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses elicited by meals containing either whole grain rye bread or white wheat bread as such or combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations are monitored from finger prick blood samples collected before the meal and at 15, 30, 45, 60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30 and 60 min.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • BMI 18-27 kg/m2

Exclusion Criteria:

  • pregnant or breastfeeding
  • diabetes, gastrointestinal disease
  • regular use of medication
  • strict vegetarian or vegan diet
  • food allergy
  • recent blood donation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wheat bread
Bread-based meal
Other: Wheat bread
Experimental: Wheat bread with margarine and ham
Bread-based meal
Other: Wheat bread
Other: margarine
Other: ham
Experimental: Wheat bread with margarine, ham and soup
Bread-based meal
Other: Wheat bread
Other: margarine
Other: ham
Other: soup
Experimental: Rye bread
Bread-based meal
Other: rye bread
Experimental: Rye bread with margarine and ham
Bread-based meal
Other: margarine
Other: ham
Other: rye bread
Experimental: Rye bread with margarine, ham and soup
Bread-based meal
Other: margarine
Other: ham
Other: soup
Other: rye bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood glucose concentration
Time Frame: 120 min
120 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum insulin concentration
Time Frame: 60 min
60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Fazer Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HY_RAV_Breadmeal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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