High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes

High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes: a Randomized, Cross-over, Acute Dietary Intervention Study.

In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of naturally produced high-amylose barley (Lean-baking barley®) on the postprandial glucose-metabolism in subjects with and without type 2 diabetes (T2D).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: 100% wheat (control); Dietary supplement: 100% Lean-baking barley®; Dietary supplement: 100% regular barley

Detailed Description

The prevalence of T2D is increasing worldwide, primarily due to obesity, lack of physical activity and unhealthy diet. Therefore, it is of great important to evolve dietary products that counteracts this development.

Barley has shown some beneficial effects on postprandial blood glucose compared with wheat. A lowering of the postprandial glucose level reduces the risk of developing T2D and helps in the regulation of a pre-existing diabetes. However, barley is traditionally not used in bread-making in Denmark.

The elevation of postprandial glucose also depends on how fast the dietary products are degraded in the gastrointestinal tract.

The starch in barley consist of both fastly degraded amylopectin and slowly degraded amylose. Slow degradation is expected to lower postprandial glucose. By natural breeding techniques it has been possible for the investigators collaborative partners at the Universities of Aarhus and Copenhagen and PlantCarb ApS to make an natural organic high-amylose barley (Lean-baking barley®).

In a series of acute studies the investigators want to study the effects on the glycemic response to bread made with different flours (wheat, regular barley, Lean-baking barley® in subjects with T2D.

The investigators expect that Lean-baking barley® positively affect the postprandial glucose-metabolism more than wheat and regular barley and hereby acutely improves the glycemic regulation for both subjects with and without T2D.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for T2D group:

• T2D defined by standard Danish guidelines.
• HbA1c between 42-78 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-diabetics; Adults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation.	Dietary supplement: 100% wheat (control); 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% Lean-baking barley®; Intake of 250 ml of tap water and 100 g of bread baked with 100% Lean-baking barley® flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flou; Dietary supplement: 100% regular barley; Intake of 250 ml of tap water and 100 g of bread baked with 100% regular barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.
Experimental: Type 2 diabetes; Adults with T2D. Hemoglobin A1C between 42-78 mmol/l. No use of insulin or once-weekly glucagon-like peptide-1 (GLP-1) or acarbose. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation.	Dietary supplement: 100% wheat (control); 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% Lean-baking barley®; Intake of 250 ml of tap water and 100 g of bread baked with 100% Lean-baking barley® flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flou; Dietary supplement: 100% regular barley; Intake of 250 ml of tap water and 100 g of bread baked with 100% regular barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glycemic response	Postprandial glycemic response 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 Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
Visual analogue scale (VAS)	VAS-score of a number of standardized questions regarding, hunger, satiety, the test meal experience etc. Each answer is ranged on a 100 mm line expressing the most positive and negative rating possible at each end.	Measured at time 0,30,60,90,120,150,180,210,240 minutes

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Innovation Fund Denmark
• Investigators: Principal Investigator: Mette B Larsen, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Glycemic index; Postprandial; Barley; High-amylose
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: HIAMBA-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No