Clinical trial NCT04646746: Acute Studies on the Glycemic Index After Intake of Different Sorts of Barley in Subjects With Type 2 Diabetes
Official title: HIAMBA-1 - the Effects of Nude Barley and Gene-modified High-amylose Barley on Postprandial Glucose Metabolism in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Glycemic index
Postprandial
Barley
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
First posted: 2020-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blinded, cross-over, acute, dietary intervention study
Primary purpose: SUPPORTIVE_CARE

Brief summary: In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of different types of barley on the glycemic index (GI) in subjects with type 2 diabetes.

The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls off during harvesting, and thereby reduces the need for processing. The investigators want to study how this ancient type of barley affects GI.

Furthermore, some of the investigators collaborative partners have made it possible to increase the amount of amylose in regular barley by genetic modification. The investigators want to study the effect on GI of this new type of modified barley.

Detailed description: Approx. 60 mio. people worldwide live with diabetes and the prevalence is increasing. The increase is primarily due to obesity, unhealthy diet and lack of physical activity. Therefore, it is important to find dietary products that counteracts this development.

Intake of food with a low glycemic index (GI) reduces the risk of developing type 2 diabetes (T2D) and helps in the regulation of a preexisting diabetes.

Barley has shown some beneficial effects on GI compared with wheat, however, barley is not commonly used in bread making in Denmark.

The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls of during harvesting, and thereby reduces the need for processing. However, it is not known how this ancient type of barley affects GI.

The composition of the starch in barley is of importance when the grain is degraded after consumption. The starch consists of both amylose (which is slowly degraded) and amylopectin (which is quickly degraded). By genetic modification, it was possible for collaborative researchers at the Universities of Aarhus and Copenhagen to increase the amount of amylose in regular barley. Slowly degraded starch is expected to decrease GI.

In a series of acute studies the investigators want to study the effects on the glucose metabolism to intake of bread made with different compositions of wheat, nude barley and gene-modified high-amylose barley in subjects with T2D.

It is expected that both nude barley and gene-modified high-amylose barley lowers the postprandial glycemic response more than wheat and hereby positively affect the glycemic regulation for subjects with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes (T2D) defined by standard Danish guidelines.
* HbA1c between 48-78 mmol/l.
* Treatment with drugs for hypertension and high cholesterol is allowed if the treatment dose is stable and does not demand changes during the study period.
* Participants are encouraged to maintain their present psychical activity level and their smoking and alcohol habits.

Exclusion Criteria:

* Type 1 diabetes
* Insulin demanding T2D
* Use of weekly administrated GLP-1 antagonist (e.g. ozempic, trulicity or byetta)
* Use of acarbose
* Significant cardiovascular, kidney, liver or endocrine comorbidity
* Significant psychiatric history
* Treatment with steroids
* Alcohol or drug abuse
* Pregnancy or breastfeeding
* Legally incompetent

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: Change from -10 minutes to 240 minutes after bread intake (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
Secondary outcomes:
measure: Postprandial insulin response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
measure: Postprandial glucagon response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
measure: Postprandial triglyceride response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
measure: Postprandial free fatty acid response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
measure: Postprandial GLP-1 (glucagon-like peptide-1) response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
measure: Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Mette B Larsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: