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

Not Applicable

Completed

• Conditions: Glycemic Index

• Registration Number: NCT03878576
• Lead Sponsor: Nutrition Institute, Slovenia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-07
• Status Verified: 2019-03
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-15
• Study First Posted: 2019-03-18
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in glycaemic response (capillary blood glucose)	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)

Trial Locations

Locations (1)

Nutrition Institite; 🇸🇮 Ljubljana, Slovenia