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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04702672
• Other study ID #: HIAMBA-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of Aarhus
• Contact: Mette B Larsen, MD, PhD
• Phone: 22620026
• Email: mette.bohl.larsen[@]aarhus.rm.dk
• 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 naturally produced high-amylose barley (Lean-baking barley®) on the postprandial glucose-metabolism in subjects with and without type 2 diabetes (T2D).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Innovation Fund Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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