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

NCT04702672 | Completed DMC

• 1 other identifier: HIAMBA-2
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 2 Diabetes

Keywords

Glycemic index; Postprandial; Barley; High-amylose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Postprandial insulin response

  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

  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

  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

  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

  Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)

Study Arms (2)

Type 2 diabetes

EXPERIMENTAL

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); Dietary Supplement: 100% Lean-baking barley®; Dietary Supplement: 100% regular barley

Non-diabetics

EXPERIMENTAL

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); Dietary Supplement: 100% Lean-baking barley®; Dietary Supplement: 100% regular barley

Interventions

100% wheat (control) DIETARY_SUPPLEMENT

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.

Non-diabetics; Type 2 diabetes

100% Lean-baking barley® DIETARY_SUPPLEMENT

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

Non-diabetics; Type 2 diabetes

100% regular barley DIETARY_SUPPLEMENT

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.

Non-diabetics; Type 2 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Innovation Fund Denmark: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Bohl M, Gregersen S, Li Z, Blennow A, Hebelstrup KH, Hermansen K. High-amylose barley bread improves postprandial glycemia compared to regular barley and wheat bread in subjects with or without type 2 diabetes. Eur J Clin Nutr. 2025 Oct;79(10):1000-1006. doi: 10.1038/s41430-025-01646-6. Epub 2025 Jul 21.

  PMID: 40691269 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Flour

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mette B Larsen, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Letter labeling of test products
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-blinded, cross-over, acute, dietary intervention study

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: January 11, 2021
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 31, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

DK (1)