Clinical trial NCT04702672: High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes
Official title: High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes: a Randomized, Cross-over, Acute Dietary Intervention Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Glycemic index
Postprandial
Barley
High-amylose
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
First posted: 2021-01-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, single-blinded, cross-over, acute, dietary intervention study
Primary purpose: PREVENTION

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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: 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:
measure: Postprandial insulin response
timeFrame: 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)
measure: Postprandial glucagon response
timeFrame: 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)
measure: Postprandial triglyceride response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
measure: Postprandial free fatty acid response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
measure: Postprandial GLP-1 (glucagon-like peptide-1) response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
measure: Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response
timeFrame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
measure: Visual analogue scale (VAS)
timeFrame: Measured at time 0,30,60,90,120,150,180,210,240 minutes
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Mette B Larsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: