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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02543164
Enrollment
10
Registered
2015-09-07
Start date
2015-02-28
Completion date
2017-09-30
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycemic Index

Keywords

Glycemic Index, glycemic response

Brief summary

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.

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.

Interventions

OTHERREFERENCE: 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).

OTHERTEST: 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).

Sponsors

Valens Int. d.o.o., Slovenija
CollaboratorINDUSTRY
Institute of Nutrition, Slovenia (Nutris)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reduced area under the curve (AUC) of blood glucose levels in bread enriched with barley beta-glucans (reduced glycemic response)up to 60 days (1 day experiments)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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026