Glycemic IndexARRS-bGL-01NCT03878576

The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar

A study testing REFERENCE: white bread - BGL0 [RP], TEST: b-glucan enriched bread - BGL2 [IP1] and TEST: b-glucan enriched bread - BGL3 [IP2] in people with Glycemic Index, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Glycemic Index
What is being tested?: REFERENCE: white bread - BGL0 [RP], TEST: b-glucan enriched bread - BGL2 [IP1] and TEST: b-glucan enriched bread - BGL3 [IP2]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteSlovenia
Study dates: 26 Nov 2018to 7 Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

Nutrition Institite
Ljubljana, 1000

Other trials in Slovenia

About this study

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.

Conditions: Glycemic Index
Being tested: REFERENCE: white bread - BGL0 [RP], TEST: b-glucan enriched bread - BGL2 [IP1], TEST: b-glucan enriched bread - BGL3 [IP2], TEST: b-glucan enriched bread - BGL4 [IP3]
Keywords: Glycemic Index, glycemic response, bread, barley, beta-glucans, glucose level, continous glucose monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03878576
Study group	Role	What they receive
REFERENCE: white bread - BGL0 [RP]	Active comparator	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. Receives: Other: REFERENCE: white bread - BGL0 [RP]
TEST: b-glucan enriched bread - BGL2 [IP1]	Experimental	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. Receives: Other: TEST: b-glucan enriched bread - BGL2 [IP1]
TEST: b-glucan enriched bread - BGL3 [IP2]	Experimental	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. Receives: Other: TEST: b-glucan enriched bread - BGL3 [IP2]
TEST: b-glucan enriched bread - BGL4 [IP3]	Experimental	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. Receives: Other: TEST: b-glucan enriched bread - BGL4 [IP3]

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 20187 Dec 2018

First posted18 Mar 2019
Study start26 Nov 2018
Primary completion7 Dec 2018
Study completion7 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Glycemic IndexStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03878576
Sponsor's protocol ID: KME/0120-441/2018/4
Acronym: ARRS-bGL-01
Status last verified: Mar 2019
First submitted: 14 Mar 2019
Last updated: 19 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar
ClinicalTrials.gov ID: NCT03878576
Acronym / sponsor ID: ARRS-bGL-01 / KME/0120-441/2018/4
Conditions: Glycemic Index
Keywords: Glycemic Index, glycemic response, bread, barley, beta-glucans, glucose level, continous glucose monitoring
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Institute of Nutrition, Slovenia (Nutris)University, hospital or other
Collaborators: Community Health Centre Ljubljana, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
Study start: 26 Nov 2018 (actual)
Primary completion: 7 Dec 2018 (actual)
Study completion: 7 Dec 2018 (actual)
First posted: 18 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
REFERENCE: white bread - BGL0 [RP]	Active comparator	Other: 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.
TEST: b-glucan enriched bread - BGL2 [IP1]	Experimental	Other: 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.
TEST: b-glucan enriched bread - BGL3 [IP2]	Experimental	Other: 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.
TEST: b-glucan enriched bread - BGL4 [IP3]	Experimental	Other: 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Igor Pravst, PhD study chair

Institut za nutricionistiko

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycaemic response (capillary blood glucose) (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.