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

Nutrition Institute, Slovenia

Status: Completed

Conditions: Glycemic Index

Treatments: Other: TEST: b-glucan enriched bread; Other: REFERENCE: white bread

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02543164

KME68/02/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

REFERENCE: white bread

Other group

Description:

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.

Treatment:

Other: REFERENCE: white bread

TEST: b-glucan enriched bread

Other group

Description:

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.

Treatment:

Other: TEST: b-glucan enriched bread