Clinical trial NCT03581266: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics
Keywords: Rye
Wheat
Rye factor
Glucose kinetics
Lead sponsor: Swedish University of Agricultural Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: CTC Clinical Trial Consultants AB
First posted: 2018-07-10
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Investigate glucose kinetics after ingestion of wheat and rye breads
timeFrame: Completed and published study within 3 years after end of sample collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Swedish University of Agricultural Sciences
name: Ali A Moazzami, PhD
role: PRINCIPAL_INVESTIGATOR
References: