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Trial record 21 of 54 for:    barley

The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar (ARRS-bGL-01)

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ClinicalTrials.gov Identifier: NCT03878576
Recruitment Status : Completed
First Posted : March 18, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Zdravstveni dom Ljubljana
Slovenian Research Agency
Valens Int. d.o.o., Slovenija
Information provided by (Responsible Party):
Nutrition Institute, Slovenia

Brief Summary:
The effect of content of barley beta-glucans in bread on postprandial blood sugar will be measured with open-label crossover study. Study will be conducted in Slovenia on 10-12 adult subjects who will test three barley beta-glucan containing bread formulations (food) in comparison with a reference white bread. Objective of the study is to investigate the influence of the content of barley beta-glucan in bread on glycaemic index (incremental area under the curve (IAUC) for the blood glucose response curve for barley beta-glucan containing breads in comparison to reference white bread.

Condition or disease Intervention/treatment Phase
Glycemic Index Other: REFERENCE: white bread - BGL0 [RP] Other: TEST: b-glucan enriched bread - BGL2 [IP1] Other: TEST: b-glucan enriched bread - BGL3 [IP2] Other: TEST: b-glucan enriched bread - BGL4 [IP3] Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : December 7, 2018
Actual Study Completion Date : December 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: REFERENCE: white bread - BGL0 [RP]
Participants consume a meal of bread BGL0 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.
Other: REFERENCE: white bread - BGL0 [RP]
Determination of glycemic response after consumption of BGL0.

Experimental: TEST: b-glucan enriched bread - BGL2 [IP1]
Participants consume a meal of bread BGL2 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.
Other: TEST: b-glucan enriched bread - BGL2 [IP1]
Determination of glycemic response after consumption of BGL0.

Experimental: TEST: b-glucan enriched bread - BGL3 [IP2]
Participants consume a meal of bread BGL3 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.
Other: TEST: b-glucan enriched bread - BGL3 [IP2]
Determination of glycemic response after consumption of BGL0.

Experimental: TEST: b-glucan enriched bread - BGL4 [IP3]
Participants consume a meal of bread BGL4 standardised to contain 25 g of available carbohydrates. Sample consumed together with 300 mL of water in up to 15 minutes.
Other: TEST: b-glucan enriched bread - BGL4 [IP3]
Determination of glycemic response after consumption of BGL0.




Primary Outcome Measures :
  1. Change in glycaemic response (capillary blood glucose) [ Time Frame: 2 hours ]
    Change in incremental area under the curve (IAUC) the blood glucose response curve for barley beta-glucan containing breads (investigational products; IP1-3), in comparison to white bread (reference product; RP)


Other Outcome Measures:
  1. Glucose level as measured with continuous glucose monitor (CGM) [ Time Frame: up to 3 hours ]


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:

  • Subject Informed consent form (ICF) is singed
  • Aged above 18 years at the time of the signature of ICF
  • No known food allergy or intolerance
  • No medications known to affect glucose tolerance — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
  • Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
  • Body mass index (BMI) > 25

Exclusion Criteria:

  • Subject Informed consent form (ICF) is singed
  • Aged above 18 years at the time of the signature of ICF
  • No known food allergy or intolerance
  • No medications known to affect glucose tolerance — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
  • Willing to follow all study procedures, including attending all site visits (including sessions for blood sampling and use of CGM)
  • Body mass index (BMI) > 25

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): NCT03878576


Locations
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Slovenia
Nutrition Institite
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Nutrition Institute, Slovenia
Zdravstveni dom Ljubljana
Slovenian Research Agency
Valens Int. d.o.o., Slovenija
Investigators
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Study Chair: Igor Pravst, PhD Institut za nutricionistiko

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Responsible Party: Nutrition Institute, Slovenia
ClinicalTrials.gov Identifier: NCT03878576     History of Changes
Other Study ID Numbers: KME/0120-441/2018/4
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nutrition Institute, Slovenia:
Glycemic Index
glycemic response
bread
barley
beta-glucans
glucose level
continous glucose monitoring