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

• ClinicalTrials.gov Identifier: NCT04646746
• Recruitment Status: Recruiting
• First Posted: November 30, 2020
• Last Update Posted: February 25, 2021
• Sponsor: University of Aarhus
• Collaborator: Innovation Fund Denmark
• Information provided by (Responsible Party): University of Aarhus

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Dietary Supplement: 100% wheat; Dietary Supplement: 50% nude barley and 50% wheat; Dietary Supplement: 75% nude barley and 25% wheat; Dietary Supplement: 50% gene-modified high-amylose barley and 50% wheat	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized, double-blinded, cross-over, acute, dietary intervention study
• Masking: Double (Participant, Investigator)
• Masking Description: Color labeling
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: February 8, 2021
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: June 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 100 g of 100% wheat bread; Intake of 250 ml of tap water and 100 g of bread baked with 100% wheat flour (regular commercial available wheat flour). Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.	Dietary Supplement: 100% wheat; 100 g of bread backed with 100% wheat
Experimental: Nude barley 50%; Intake of 250 ml of tap water and 100 g of bread baked with 50% nude barley flour and 50% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.	Dietary Supplement: 50% nude barley and 50% wheat; 100 g of bread backed with 50% nude barley and 50% wheat
Experimental: Nude barley 75%; Intake of 250 ml of tapwater and 100 g of bread baked with 75% nude barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.	Dietary Supplement: 75% nude barley and 25% wheat; 100 g of bread backed with 75% of nude barley and 25% wheat
Experimental: Gen-modified high-amylose barley; Intake of 250 ml of tap water and 100 g of bread baked with 50% gene-modified high-amylose barley and 50% wheat. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. The gene-modified barley is produced by researchers at Aarhus and Copenhagen Universities as published in 'Carciofi M, et al., Concerted suppression of all starch branching enzyme genes in barley produces amylose-only starch granules. BMC Plant Biol. 2012 Nov 21;12:223. doi: 10.1186/1471-2229-12-223' The wheat flour is standard commercial available flour.	Dietary Supplement: 50% gene-modified high-amylose barley and 50% wheat; 100 g of bread backed with 50% gene-modified high-amylose barley and 50% wheat

Outcome Measures

Primary Outcome Measures :

1. Postprandial glycemic response [ Time Frame: 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) ]
   Area under the curve for glucose (mmol/L)

Secondary Outcome Measures :

1. Postprandial insulin response [ Time Frame: 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) ]
   Area under the curve for insulin (pmol/L)
2. Postprandial glucagon response [ Time Frame: 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) ]
   Area under the curve for glucagon (pg/mL)
3. Postprandial triglyceride response [ Time Frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) ]
   Area under the curve for triglyceride (mmol/L)
4. Postprandial free fatty acid response [ Time Frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) ]
   Area under the curve for free fatty acids (mmol/L)
5. Postprandial GLP-1 (glucagon-like peptide-1) response [ Time Frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) ]
   Area under the curve for GLP-1 (pmol/L)
6. Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response [ Time Frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) ]
   Area under the curve for GIP (pmol/L)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Mette B Larsen, MD, PhD; +45 22620026; mette.bohl.larsen@aarhus.rm.dk

Locations

Denmark

Aarhus University Hospital; Recruiting

Aarhus, Denmark, 8200

Contact: Mette B Larsen, MD, PhD 22620026 Mette.Bohl.Larsen@aarhus.rm.dkcom

Sponsors and Collaborators

University of Aarhus

Innovation Fund Denmark

Investigators

• Principal Investigator: Mette B Larsen, MD, PhD; Aarhus University Hospital

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04646746
• Other Study ID Numbers: HIAMBA-1
• First Posted: November 30, 2020
• Last Update Posted: February 25, 2021
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:

Glycemic index; Postprandial; Barley

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases