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

Glycemic Index Clinical Trial

— ARRS-bGL-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878576
• Other study ID #: KME/0120-441/2018/4
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: December 7, 2018

Study information

• Verified date: March 2019
• Source: Nutrition Institute, Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 7, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glycemic Index

Intervention

Other:
• REFERENCE: white bread - BGL0 [RP]
Determination of glycemic response after consumption of BGL0.
• TEST: b-glucan enriched bread - BGL2 [IP1]
Determination of glycemic response after consumption of BGL0.
• TEST: b-glucan enriched bread - BGL3 [IP2]
Determination of glycemic response after consumption of BGL0.
• TEST: b-glucan enriched bread - BGL4 [IP3]
Determination of glycemic response after consumption of BGL0.

Locations

Country	Name	City	State
Slovenia	Nutrition Institite	Ljubljana

Sponsors (4)

Lead Sponsor	Collaborator
Nutrition Institute, Slovenia	Slovenian Research Agency, Valens Int. d.o.o., Slovenija, Zdravstveni dom Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glucose level as measured with continuous glucose monitor (CGM)		up to 3 hours
Primary	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