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

University of Aarhus

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: 100% regular barley; Dietary Supplement: 100% Lean-baking barley®; Dietary Supplement: 100% wheat (control)

Study type: Interventional

Funder types: Other

Identifiers

NCT04702672

HIAMBA-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Type 2 diabetes

Experimental group

Description:

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.

Treatment:

Dietary Supplement: 100% wheat (control)

Dietary Supplement: 100% Lean-baking barley®

Dietary Supplement: 100% regular barley

Non-diabetics

Experimental group

Description:

Adults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation.

Treatment:

Dietary Supplement: 100% wheat (control)

Dietary Supplement: 100% Lean-baking barley®

Dietary Supplement: 100% regular barley