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Glucose Kinetics After Wheat and Rye Breads

Primary Purpose

Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rye/Wheat
Sponsored by
Swedish University of Agricultural Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics focused on measuring Rye, Wheat, Rye factor, Glucose kinetics

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Males 18-40 years with BMI 22-25.5 kg/m2

Exclusion Criteria:

  • A family history of diabetes mellitus, regular use of nicotine, recurrent extensive exercise, regular intake of medication or food intolerances. The subjects had to be free from illnesses for one month prior to the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Rye

    Wheat

    Arm Description

    A breakfast consisting of whole slices of wholemeal rye bread containing 50 g of available carbohydrates. The breakfast additionally included 250 mL water and 50 g of cucumber.

    A breakfast consisting of whole slices of refined wheat bread containing 50 g of available carbohydrates. The breakfast additionally included 250 mL water and 50 g of cucumber.

    Outcomes

    Primary Outcome Measures

    Investigate glucose kinetics after ingestion of wheat and rye breads
    Glucose kinetics are investigated after ingestions of two different kinds of bread based breakfasts in order to see how the body responds to the different breads.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 26, 2018
    Last Updated
    June 26, 2018
    Sponsor
    Swedish University of Agricultural Sciences
    Collaborators
    Uppsala University, CTC Clinical Trial Consultants AB
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03581266
    Brief Title
    Glucose Kinetics After Wheat and Rye Breads
    Official Title
    Determination of Glucose Kinetics After Wheat and Rye Breads to Understand Their Physiological Effects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    November 30, 2015 (Actual)
    Study Completion Date
    November 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Swedish University of Agricultural Sciences
    Collaborators
    Uppsala University, CTC Clinical Trial Consultants AB

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Certain functional properties of cereal products, e.g. their postprandial glucose and insulin responses, have been characterized as steps towards obtaining a greater understanding of their beneficial health effects. A low-glycemic index diet results in decreased postprandial insulin and glucose responses, which is thought to be beneficial for insulin and glucose metabolism. In healthy subjects, it has been shown that rye breads (RBs) produce a lower postprandial insulin response compared with refined wheat breads (RWB) despite similar glucose responses. Juntunen et al. (2003) suggested that the difference in the structural characteristics between rye and wheat breads is a possible explanatory mechanism. However, the underlying mechanism of this discrepancy between insulin and glucose responses to rye bread, the so-called "rye factor" (RF), is still largely unknown. Faster starch digestibility and higher postprandial insulin responses for RWB compared with RBs may indicate faster intestinal glucose absorption and faster glucose disappearance respectively. Therefore our hypothesis is that despite having similar glucose responses, RWB has faster turn over (kinetics) compared with RBs. The present study is aiming to apply an experimental set up which can comprehend the hypothetical differences in RWB and RBs kinetics.
    Detailed Description
    The human subjects after an overnight fasting 10-12 hours are coming to the clinic. On arrival, catheters are inserted into a forearm vein of each arm for blood sampling and isotope infusion, respectively. A primed followed by a constant-rate infusion of [6,6-2H2] glucose are administered. The enrichment of [6,6-2H2] glucose in the blood is then measured at different time points after the breakfast. The glucose kinetics can be calculated from this.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics
    Keywords
    Rye, Wheat, Rye factor, Glucose kinetics

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    The study was carried out using a crossover design with a three-week washout period. The participants stayed overnight at the facility and had one out of two types of breakfast in the morning.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rye
    Arm Type
    Experimental
    Arm Description
    A breakfast consisting of whole slices of wholemeal rye bread containing 50 g of available carbohydrates. The breakfast additionally included 250 mL water and 50 g of cucumber.
    Arm Title
    Wheat
    Arm Type
    Experimental
    Arm Description
    A breakfast consisting of whole slices of refined wheat bread containing 50 g of available carbohydrates. The breakfast additionally included 250 mL water and 50 g of cucumber.
    Intervention Type
    Other
    Intervention Name(s)
    Rye/Wheat
    Intervention Description
    Mechanistic study of glucose kinetics after ingestion two kinds of bread
    Primary Outcome Measure Information:
    Title
    Investigate glucose kinetics after ingestion of wheat and rye breads
    Description
    Glucose kinetics are investigated after ingestions of two different kinds of bread based breakfasts in order to see how the body responds to the different breads.
    Time Frame
    Completed and published study within 3 years after end of sample collection

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Only males were recruited
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males 18-40 years with BMI 22-25.5 kg/m2 Exclusion Criteria: A family history of diabetes mellitus, regular use of nicotine, recurrent extensive exercise, regular intake of medication or food intolerances. The subjects had to be free from illnesses for one month prior to the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali A Moazzami, PhD
    Organizational Affiliation
    Swedish University of Agricultural Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Glucose Kinetics After Wheat and Rye Breads

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