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Trial record 65 of 7559 for:    Area Under Curve

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

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ClinicalTrials.gov Identifier: NCT02543164
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
Valens Int. d.o.o., Slovenija
Information provided by (Responsible Party):
Snežana Kocijančič, Nutrition Institute, Slovenia

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.

Condition or disease Intervention/treatment Phase
Glycemic Index Other: REFERENCE: white bread Other: TEST: b-glucan enriched bread Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : February 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
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).


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).





Primary Outcome Measures :
  1. 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) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543164


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

Publications:
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Responsible Party: Snežana Kocijančič, Ms., Nutrition Institute, Slovenia
ClinicalTrials.gov Identifier: NCT02543164     History of Changes
Other Study ID Numbers: KME68/02/15
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Keywords provided by Snežana Kocijančič, Nutrition Institute, Slovenia:
Glycemic Index
glycemic response