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

NCT02543164 | Completed

• 1 other identifier: KME68/02/15
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glycemic Index

Keywords

Glycemic Index; glycemic response

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

REFERENCE: white bread

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.

Other: REFERENCE: white bread

TEST: b-glucan enriched bread

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.

Other: TEST: b-glucan enriched bread

Interventions

REFERENCE: white bread OTHER

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).

REFERENCE: white bread

TEST: b-glucan enriched bread OTHER

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).

TEST: b-glucan enriched bread

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• Valens Int. d.o.o., Slovenija: collaborator

Related Publications (1)

• 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.

  PMID: 19079901 BACKGROUND

Study Officials

• Igor Pravst

  Institute of Nutrition, Slovenia (Nutris)

  STUDY CHAIR

• Snežana Kocijančič

  Institute of Nutrition, Slovenia (Nutris)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms.

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 7, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-09