Influence of Beta-glucan Enriched Barley Flour in Bread on Glycemic Response

Comparison of the Glycemic Response of Consumption of Bread Enriched With Barley Beta-glucans With White Bread. Controlled Intervention Trial. A Pilot Study

Objective of the study is to investigate the influence of beta-glucan enriched barley flour as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic response will be measured as AUC of blood glucose after consumption of barley bread, and compared with white bread.

Study Overview

• Status: Completed
• Conditions: Glycemic Index
• Intervention / Treatment: Other: REFERENCE: white bread; Other: TEST: b-glucan enriched bread

Detailed Description

Objective of the study is to investigate the influence of beta-glucan enriched barley flour as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic response will be measured as the area under the curve (AUC) of blood glucose after consumption of barley bread(s), and compared with AUC for white bread. Measurements will be done in line with recommendations. In line with recommendations ten healthy human volunteers will be tested to obtain a sufficient statistical power. GR measurement will be based on available carbohydrates. Amount of bread will be standardised to contain 50 g of available carbohydrates. Subjects will consume bread sample with 250 mL of water, within 10-15 minutes. Blood sampling times will be at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the test meal. Glucose levels will be measured in capillary blood. For reference and test meals, the investigators will do at least 2 AUC measurements per subject. AUC calculation will be based on incremental AUC, ignoring area under the baseline. Comparison will be done as the mean of the individual ratios.

The differences between the different products ingested will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Kruskal-Wallis test, will be used. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willingness' to participate, self-diagnosed as healthy
• Age: 18-65 years

Exclusion Criteria:

• Allergy or intolerances to ingredients of tested products (bread)
• Renal impairment
• Diagnosed diabetes
• Level of glucose above 5.6mmol/l at first measurement
• Thyroid disease
• Use of medicines for lowering blood fats and/or preparations for weight loss or reducing the absorption of nutrients from the digestive tract

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: REFERENCE: white bread; Participants will consume a meal standardised to contain 50 g of available carbohydrates. Sample Will be consumed together with 250 mL of water, within 10-15 minutes.	Other: REFERENCE: white bread; Determination of glycemic response after consumption of white bread: Capillary glucose will be taken at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC).
Other: TEST: b-glucan enriched bread; Participants will consume a meal standardised to contain 50 g of available carbohydrates. Sample Will be consumed together with 250 mL of water, within 10-15 minutes.	Other: TEST: b-glucan enriched bread; Determination of glycemic response after consumption of bread enriched with barley beta-glucans (Test A) : Capillary glucose will be taken at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced area under the curve (AUC) of blood glucose levels in bread enriched with barley beta-glucans (reduced glycemic response)	Glycaemic response will be measured as the area under the curve (AUC) of blood glucose after consumption of barley bread(s), and compared with AUC for white bread. Blood sampling times will be at 0 min (baseline sample), followed by 15, 30, 45, 60, 75, 90 and 120 min after starting to eat the test meal. Glucose levels will be measured in capillary blood. AUC calculation will be based on incremental AUC, ignoring area under the baseline. Comparison will be done as the mean of the individual ratios. Primary outcome measure is significant reducment of AUC for bread enriched with barley beta-glucans (P<0.05).	up to 60 days (1 day experiments)

Collaborators and Investigators

• Sponsor: Nutrition Institute, Slovenia
• Collaborators: Valens Int. d.o.o., Slovenija
• Investigators: Study Chair: Igor Pravst, Nutrition Institute, Slovenia; Principal Investigator: Snežana Kocijančič, Nutrition Institute, Slovenia

Publications and helpful links

General Publications

• Brouns F, Bjorck I, Frayn KN, Gibbs AL, Lang V, Slama G, Wolever TM. Glycaemic index methodology. Nutr Res Rev. 2005 Jun;18(1):145-71. doi: 10.1079/NRR2005100.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Glycemic Index; glycemic response
• Other Study ID Numbers: KME68/02/15