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

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
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
NCT ID
NCT03581266
First Posted
June 26, 2018
Last Updated
June 26, 2018
Sponsor
Swedish University of Agricultural Sciences
Collaborators
Uppsala University, CTC Clinical Trial Consultants AB
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
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Glucose Kinetics After Wheat and Rye Breads
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