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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
100% wheat
50% nude barley and 50% wheat
75% nude barley and 25% wheat
50% gene-modified high-amylose barley and 50% wheat
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Glycemic index, Postprandial, Barley

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

100 g of 100% wheat bread

Nude barley 50%

Nude barley 75%

Gen-modified high-amylose barley

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Postprandial glycemic response
Area under the curve for glucose (mmol/L)

Secondary Outcome Measures

Postprandial insulin response
Area under the curve for insulin (pmol/L)
Postprandial glucagon response
Area under the curve for glucagon (pg/mL)
Postprandial triglyceride response
Area under the curve for triglyceride (mmol/L)
Postprandial free fatty acid response
Area under the curve for free fatty acids (mmol/L)
Postprandial GLP-1 (glucagon-like peptide-1) response
Area under the curve for GLP-1 (pmol/L)
Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response
Area under the curve for GIP (pmol/L)

Full Information

First Posted
November 16, 2020
Last Updated
May 5, 2022
Sponsor
University of Aarhus
Collaborators
Innovation Fund Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04646746
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Innovation Fund Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Glycemic index, Postprandial, Barley

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blinded, cross-over, acute, dietary intervention study
Masking
ParticipantInvestigator
Masking Description
Color labeling
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100 g of 100% wheat bread
Arm Type
Experimental
Arm Description
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.
Arm Title
Nude barley 50%
Arm Type
Experimental
Arm Description
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.
Arm Title
Nude barley 75%
Arm Type
Experimental
Arm Description
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.
Arm Title
Gen-modified high-amylose barley
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
100% wheat
Intervention Description
100 g of bread backed with 100% wheat
Intervention Type
Dietary Supplement
Intervention Name(s)
50% nude barley and 50% wheat
Intervention Description
100 g of bread backed with 50% nude barley and 50% wheat
Intervention Type
Dietary Supplement
Intervention Name(s)
75% nude barley and 25% wheat
Intervention Description
100 g of bread backed with 75% of nude barley and 25% wheat
Intervention Type
Dietary Supplement
Intervention Name(s)
50% gene-modified high-amylose barley and 50% wheat
Intervention Description
100 g of bread backed with 50% gene-modified high-amylose barley and 50% wheat
Primary Outcome Measure Information:
Title
Postprandial glycemic response
Description
Area under the curve for glucose (mmol/L)
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)
Secondary Outcome Measure Information:
Title
Postprandial insulin response
Description
Area under the curve for insulin (pmol/L)
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)
Title
Postprandial glucagon response
Description
Area under the curve for glucagon (pg/mL)
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)
Title
Postprandial triglyceride response
Description
Area under the curve for triglyceride (mmol/L)
Time Frame
Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Title
Postprandial free fatty acid response
Description
Area under the curve for free fatty acids (mmol/L)
Time Frame
Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Title
Postprandial GLP-1 (glucagon-like peptide-1) response
Description
Area under the curve for GLP-1 (pmol/L)
Time Frame
Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Title
Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response
Description
Area under the curve for GIP (pmol/L)
Time Frame
Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette B Larsen, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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