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

NCT ID: NCT03878576

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2018-12-07

Brief Summary

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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.

Detailed Description

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Conditions

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Glycemic Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

REFERENCE: white bread - BGL0 [RP]

Intervention Type OTHER

Determination of glycemic response after consumption of BGL0.

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Determination of glycemic response after consumption of BGL0.

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Determination of glycemic response after consumption of BGL0.

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Determination of glycemic response after consumption of BGL0.

Interventions

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REFERENCE: white bread - BGL0 [RP]

Determination of glycemic response after consumption of BGL0.

Intervention Type OTHER

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

Determination of glycemic response after consumption of BGL0.

Intervention Type OTHER

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

Determination of glycemic response after consumption of BGL0.

Intervention Type OTHER

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

Determination of glycemic response after consumption of BGL0.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Community Health Centre Ljubljana

OTHER

Sponsor Role collaborator

Slovenian Research Agency

OTHER

Sponsor Role collaborator

Valens Int. d.o.o., Slovenija

INDUSTRY

Sponsor Role collaborator

Institute of Nutrition, Slovenia (Nutris)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor Pravst, PhD

Role: STUDY_CHAIR

Institut za nutricionistiko

Locations

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Nutrition Institite

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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KME/0120-441/2018/4

Identifier Type: -

Identifier Source: org_study_id

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