Overview

This trial is active, not recruiting.

Condition glycemic index
Treatments reference: white bread, test a: b-glucan enriched bread, test b: b-glucan enriched bread
Sponsor Nutrition Institute, Slovenia
Collaborator Valens Int. d.o.o., Slovenija
Start date February 2015
End date December 2017
Trial size 10 participants
Trial identifier NCT02543164, KME68/02/15

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(s), and compared with white bread.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Other)
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.
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, 75, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC).
(Other)
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.
test a: 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, 75, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC).
(Other)
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.
test b: b-glucan enriched bread
Determination of glycemic response after consumption of bread enriched with barley beta-glucans (Test B) : Bread TEST B Will be formulated to contain 50% more beta-glucans as bread TEST A. Capillary glucose will be taken at 0 min (baseline sample), followed by 15, 30, 45, 60, 75, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC). NOTE: This intervention is optional and might be performed after evaluation of intervention with Test A.

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Comparison of the Glycemic Response of Consumption of Bread Enriched With Barley Beta-glucans With White Bread. Controlled Intervention Trial. A Pilot Study
Principal investigator Snežana Kocijančič
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, 75, 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Nutrition Institute, Slovenia.