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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03878576
Other study ID # KME/0120-441/2018/4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2018
Est. completion date December 7, 2018

Study information

Verified date March 2019
Source Nutrition Institute, Slovenia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 7, 2018
Est. primary completion date December 7, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
REFERENCE: white bread - BGL0 [RP]
Determination of glycemic response after consumption of BGL0.
TEST: b-glucan enriched bread - BGL2 [IP1]
Determination of glycemic response after consumption of BGL0.
TEST: b-glucan enriched bread - BGL3 [IP2]
Determination of glycemic response after consumption of BGL0.
TEST: b-glucan enriched bread - BGL4 [IP3]
Determination of glycemic response after consumption of BGL0.

Locations

Country Name City State
Slovenia Nutrition Institite Ljubljana

Sponsors (4)

Lead Sponsor Collaborator
Nutrition Institute, Slovenia Slovenian Research Agency, Valens Int. d.o.o., Slovenija, Zdravstveni dom Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Other Glucose level as measured with continuous glucose monitor (CGM) up to 3 hours
Primary Change in glycaemic response (capillary blood glucose) 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) 2 hours
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