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Completed

NCT Number: NCT04646746

Acute Studies on the Glycemic Index After Intake of Different Sorts of Barley in Subjects With Type 2 Diabetes

In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of different types of barley on the glycemic index (GI) in subjects with type 2 diabetes.

The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls off during harvesting, and thereby reduces the need for processing. The investigators want to study how this ancient type of barley affects GI.

Furthermore, some of the investigators collaborative partners have made it possible to increase the amount of amylose in regular barley by genetic modification. The investigators want to study the effect on GI of this new type of modified barley.

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Key information

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

Approx. 60 mio. people worldwide live with diabetes and the prevalence is increasing. The increase is primarily due to obesity, unhealthy diet and lack of physical activity. Therefore, it is important to find dietary products that counteracts this development.

Intake of food with a low glycemic index (GI) reduces the risk of developing type 2 diabetes (T2D) and helps in the regulation of a preexisting diabetes.

Barley has shown some beneficial effects on GI compared with wheat, however, barley is not commonly used in bread making in Denmark.

The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls of during harvesting, and thereby reduces the need for processing. However, it is not known how this ancient type of barley affects GI.

The composition of the starch in barley is of importance when the grain is degraded after consumption. The starch consists of both amylose (which is slowly degraded) and amylopectin (which is quickly degraded). By genetic modification, it was possible for collaborative researchers at the Universities of Aarhus and Copenhagen to increase the amount of amylose in regular barley. Slowly degraded starch is expected to decrease GI.

In a series of acute studies the investigators want to study the effects on the glucose metabolism to intake of bread made with different compositions of wheat, nude barley and gene-modified high-amylose barley in subjects with T2D.

It is expected that both nude barley and gene-modified high-amylose barley lowers the postprandial glycemic response more than wheat and hereby positively affect the glycemic regulation for subjects with type 2 diabetes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes (T2D) defined by standard Danish guidelines.
  • HbA1c between 48-78 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

Dietary Supplement

100 g of bread backed with 100% wheat

50% nude barley and 50% wheat

Dietary Supplement

100 g of bread backed with 50% nude barley and 50% wheat

75% nude barley and 25% wheat

Dietary Supplement

100 g of bread backed with 75% of nude barley and 25% wheat

50% gene-modified high-amylose barley and 50% wheat

Dietary Supplement

100 g of bread backed with 50% gene-modified high-amylose barley and 50% wheat

Primary outcomes

  1. Postprandial glycemic response

    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)

    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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Innovation Fund Denmark

Registry information

Official study title

HIAMBA-1 - the Effects of Nude Barley and Gene-modified High-amylose Barley on Postprandial Glucose Metabolism in Subjects With Type 2 Diabetes

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 30, 2020
Registry last updated
May 6, 2022

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

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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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