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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03581266
Other study ID # 2014/290
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2015
Est. completion date November 30, 2015

Study information

Verified date June 2018
Source Swedish University of Agricultural Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 30, 2015
Est. primary completion date November 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rye/Wheat
Mechanistic study of glucose kinetics after ingestion two kinds of bread

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Swedish University of Agricultural Sciences Clinical Trial Consultants, CTC, Uppsala University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Completed and published study within 3 years after end of sample collection