Acute Studies on the Glycemic Index After Intake of Different Sorts of Barley in Subjects With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646746
• Other study ID #: HIAMBA-1
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: October 29, 2021

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• 100% wheat
100 g of bread backed with 100% wheat
• 50% nude barley and 50% wheat
100 g of bread backed with 50% nude barley and 50% wheat
• 75% nude barley and 25% wheat
100 g of bread backed with 75% of nude barley and 25% wheat
• 50% gene-modified high-amylose barley and 50% wheat
100 g of bread backed with 50% gene-modified high-amylose barley and 50% wheat

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Innovation Fund Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic response	Area under the curve for glucose (mmol/L)	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	Postprandial insulin response	Area under the curve for insulin (pmol/L)	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)
Secondary	Postprandial glucagon response	Area under the curve for glucagon (pg/mL)	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)
Secondary	Postprandial triglyceride response	Area under the curve for triglyceride (mmol/L)	Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Secondary	Postprandial free fatty acid response	Area under the curve for free fatty acids (mmol/L)	Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Secondary	Postprandial GLP-1 (glucagon-like peptide-1) response	Area under the curve for GLP-1 (pmol/L)	Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Secondary	Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response	Area under the curve for GIP (pmol/L)	Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)