NCT04646746

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

November 16, 2020

Last Update Submit

May 5, 2022

Conditions

Type 2 Diabetes

Keywords

Glycemic indexPostprandialBarley

Outcome Measures

Primary Outcomes (1)

  • Postprandial glycemic response

    Area under the curve for glucose (mmol/L)

    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 (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (4)

100 g of 100% wheat bread

EXPERIMENTAL

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.

Dietary Supplement: 100% wheat

Nude barley 50%

EXPERIMENTAL

Intake of 250 ml of tap water and 100 g of bread baked with 50% nude barley flour and 50% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.

Dietary Supplement: 50% nude barley and 50% wheat

Nude barley 75%

EXPERIMENTAL

Intake of 250 ml of tapwater and 100 g of bread baked with 75% nude barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.

Dietary Supplement: 75% nude barley and 25% wheat

Gen-modified high-amylose barley

EXPERIMENTAL

Intake of 250 ml of tap water and 100 g of bread baked with 50% gene-modified high-amylose barley and 50% wheat. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. The gene-modified barley is produced by researchers at Aarhus and Copenhagen Universities as published in 'Carciofi M, et al., Concerted suppression of all starch branching enzyme genes in barley produces amylose-only starch granules. BMC Plant Biol. 2012 Nov 21;12:223. doi: 10.1186/1471-2229-12-223' The wheat flour is standard commercial available flour.

Dietary Supplement: 50% gene-modified high-amylose barley and 50% wheat

Interventions

100% wheatDIETARY_SUPPLEMENT

100 g of bread backed with 100% wheat

100 g of 100% wheat bread
50% nude barley and 50% wheatDIETARY_SUPPLEMENT

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

Nude barley 50%
75% nude barley and 25% wheatDIETARY_SUPPLEMENT

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

Nude barley 75%
50% gene-modified high-amylose barley and 50% wheatDIETARY_SUPPLEMENT

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

Gen-modified high-amylose barley

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Bohl M, Gregersen S, Zhong Y, Hebelstrup KH, Hermansen K. Beneficial glycaemic effects of high-amylose barley bread compared to wheat bread in type 2 diabetes. Eur J Clin Nutr. 2024 Mar;78(3):243-250. doi: 10.1038/s41430-023-01364-x. Epub 2023 Nov 8.

    PMID: 37940671DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Flour

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Color labeling
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized, double-blinded, cross-over, acute, dietary intervention study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 30, 2020

Study Start

February 8, 2021

Primary Completion

October 29, 2021

Study Completion

October 29, 2021

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations

DK(1)