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Completed

NCT Number: NCT03878576

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

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.

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Key information

Conditions

Glycemic Index

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Institite

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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

Treatment and study plan

REFERENCE: white bread - BGL0 [RP]

Other

Determination of glycemic response after consumption of BGL0.

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

Other

Determination of glycemic response after consumption of BGL0.

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

Other

Determination of glycemic response after consumption of BGL0.

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

Other

Determination of glycemic response after consumption of BGL0.

Primary outcomes

  1. Change in glycaemic response (capillary blood glucose)

    Time frame: 2 hours

    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)

Other outcomes

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

    Time frame: up to 3 hours

Sponsors and collaborators

Lead sponsor

Institute of Nutrition, Slovenia (Nutris)

Other

Collaborators

  • Community Health Centre Ljubljana
  • Slovenian Research Agency
  • Valens Int. d.o.o., Slovenija

Registry information

Acronym: ARRS-bGL-01

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2019
Registry last updated
Mar 19, 2019

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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