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

Study Overview
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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.

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

Conditions
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Glycemic Index

Intervention / Treatment
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* Other: REFERENCE: white bread - BGL0 [RP]
* Other: TEST: b-glucan enriched bread - BGL2 [IP1]
* Other: TEST: b-glucan enriched bread - BGL3 [IP2]
* Other: TEST: b-glucan enriched bread - BGL4 [IP3]


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: REFERENCE: white bread - BGL0 [RP]<br>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]<br>* Determination of glycemic response after consumption of BGL0.<br>|
| Experimental: TEST: b-glucan enriched bread - BGL2 [IP1]<br>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]<br>* Determination of glycemic response after consumption of BGL0.<br>|
| Experimental: TEST: b-glucan enriched bread - BGL3 [IP2]<br>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]<br>* Determination of glycemic response after consumption of BGL0.<br>|
| Experimental: TEST: b-glucan enriched bread - BGL4 [IP3]<br>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]<br>* Determination of glycemic response after consumption of BGL0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Index, glycemic response, bread, barley, beta-glucans, glucose level, continous glucose monitoring