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CompletedNCT03878576ARRS-bGL-01Updated Mar 19, 2019

The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar

An interventional study of REFERENCE: white bread - BGL0 [RP] and TEST: b-glucan enriched bread - BGL2 [IP1] in Glycemic Index, sponsored by Nutrition Institute, Slovenia. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-19.

Sponsored by Nutrition Institute, Slovenia · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2018, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The effect of content of barley beta-glucans in bread on postprandial blood sugar will be measured with open-label crossover study. Study will be conducted in Slovenia on 10-12 adult subjects who will test three barley beta-glucan containing bread formulations (food) in comparison with a reference white bread. Objective of the study is to investigate the influence of the content of barley beta-glucan in bread on glycaemic index (incremental area under the curve (IAUC) for the blood glucose response curve for barley beta-glucan containing breads in comparison to reference white bread.

02

Conditions studied

  • Glycemic Index

Keywords

  • Glycemic Index
  • glycemic response
  • bread
  • barley
  • beta-glucans
  • glucose level
  • continous glucose monitoring
03

In context

Lead sponsor

Nutrition Institute, Slovenia is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject Informed consent form (ICF) is singed
  • Aged above 18 years at the time of the signature of ICF
  • No known food allergy or intolerance
  • No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
  • Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
  • Body mass index (BMI) > 25

Exclusion criteria

Exclusion Criteria:

  • Subject Informed consent form (ICF) is singed
  • Aged above 18 years at the time of the signature of ICF
  • No known food allergy or intolerance
  • No medications known to affect glucose tolerance - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
  • Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
  • Body mass index (BMI) > 25
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    REFERENCE: white bread - BGL0 [RP]

    Participants consume a meal of bread BGL0 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

    Other: REFERENCE: white bread - BGL0 [RP]

  • Experimental
    TEST: b-glucan enriched bread - BGL2 [IP1]

    Participants consume a meal of bread BGL2 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

    Other: TEST: b-glucan enriched bread - BGL2 [IP1]

  • Experimental
    TEST: b-glucan enriched bread - BGL3 [IP2]

    Participants consume a meal of bread BGL3 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

    Other: TEST: b-glucan enriched bread - BGL3 [IP2]

  • Experimental
    TEST: b-glucan enriched bread - BGL4 [IP3]

    Participants consume a meal of bread BGL4 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.

    Other: TEST: b-glucan enriched bread - BGL4 [IP3]

Interventions

  • OtherREFERENCE: white bread - BGL0 [RP]

    Determination of glycemic response after consumption of BGL0.

  • OtherTEST: b-glucan enriched bread - BGL2 [IP1]

    Determination of glycemic response after consumption of BGL0.

  • OtherTEST: b-glucan enriched bread - BGL3 [IP2]

    Determination of glycemic response after consumption of BGL0.

  • OtherTEST: b-glucan enriched bread - BGL4 [IP3]

    Determination of glycemic response after consumption of BGL0.

06

What researchers measure

Primary outcomes

  1. Change in glycaemic response (capillary blood glucose)

    Change in incremental area under the curve (IAUC) the blood glucose response curve for barley beta-glucan containing breads (investigational products; IP1-3), in comparison to white bread (reference product; RP)

    Time frame: 2 hours

Other outcomes

  1. Glucose level as measured with continuous glucose monitor (CGM)

    Time frame: up to 3 hours

07

Study locations

1 site
  • Nutrition Institite
    Ljubljana, 1000, Slovenia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03878576
Lead sponsor
Nutrition Institute, Slovenia
Collaborators
Community Health Centre Ljubljana, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
Responsible party
Sponsor
First posted
Mar 18, 2019
Start date
Nov 26, 2018
Primary completion
Dec 7, 2018
Completion
Dec 7, 2018
Last update
Mar 19, 2019

Study contacts

Igor Pravst, PhD
study chair · Institut za nutricionistiko

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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