The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar (ARRS-bGL-01)

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.

Study Overview

• Status: Completed
• Conditions: Glycemic Index
• Intervention / Treatment: 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]

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Nutrition Institite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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]; Determination of glycemic response after consumption of BGL0.
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]; Determination of glycemic response after consumption of BGL0.
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]; Determination of glycemic response after consumption of BGL0.
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]; Determination of glycemic response after consumption of BGL0.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Glucose level as measured with continuous glucose monitor (CGM)	up to 3 hours

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: Slovenian Research Agency; Valens Int. d.o.o., Slovenija; Community Health Centre Ljubljana
• Investigators: Study Chair: Igor Pravst, PhD, Institut za nutricionistiko

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): December 7, 2018
• Study Completion (Actual): December 7, 2018

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Glycemic Index; beta-glucans; glycemic response; barley; bread; glucose level; continous glucose monitoring
• Other Study ID Numbers: KME/0120-441/2018/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No