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NCT Number: NCT04702672

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

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).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Postprandial glycemic response

    Time frame: 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)

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

Secondary outcomes

  1. Postprandial insulin response

    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)

    Area under the curve for insulin (pmol/L)

  2. Postprandial glucagon response

    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)

    Area under the curve for glucagon (pg/mL)

  3. Postprandial triglyceride response

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

    Area under the curve for triglyceride (mmol/L)

  4. Postprandial free fatty acid response

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

    Area under the curve for free fatty acids (mmol/L)

  5. Postprandial GLP-1 (glucagon-like peptide-1) response

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

    Area under the curve for GLP-1 (pmol/L)

  6. Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response

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

    Area under the curve for GIP (pmol/L)

  7. Visual analogue scale (VAS)

    Time frame: Measured at time 0,30,60,90,120,150,180,210,240 minutes

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Innovation Fund Denmark

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2021
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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