Glycemic IndexNCT02543164
Influence of Beta-glucan Enriched Barley Flour in Bread on Glycemic Response
A study testing REFERENCE: white bread and TEST: b-glucan enriched bread in people with Glycemic Index, run by Institute of Nutrition, Slovenia (Nutris).
Trial 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. Read more about this study
- 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 and TEST: b-glucan enriched bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Sep 2017
- 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
- Willingness' to participate, self-diagnosed as healthy
- Age: 18-65 years
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Glycemic Index
- Being tested
- REFERENCE: white bread, TEST: b-glucan enriched bread
- Keywords
- Glycemic Index, glycemic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFERENCE: white breadOther
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 breadOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: TEST: b-glucan enriched bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 60 days (1 day experiments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- Valens Int. d.o.o., Slovenija
- Responsible party
- Principal investigator, Snežana Kocijančič, Institute of Nutrition, Slovenia (Nutris)
- Investigators
- Igor Pravst, Study chair, Institute of Nutrition, Slovenia (Nutris)Snežana Kocijančič, Principal investigator, Institute of Nutrition, Slovenia (Nutris)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543164
- Sponsor's protocol ID
- KME68/02/15
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2015
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19079901
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02543164
- Acronym / sponsor ID
- KME68/02/15
- Conditions
- Glycemic Index
- Keywords
- Glycemic Index, glycemic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- Valens Int. d.o.o., Slovenija
- Study start
- Feb 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REFERENCE: white bread | Other | Other: REFERENCE: white breadParticipants 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. |
| TEST: b-glucan enriched bread | Other | Other: TEST: b-glucan enriched breadParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willingness' to participate, self-diagnosed as healthy
- Age: 18-65 years
Key exclusion criteria (6 listed)
- 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
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 breadDetermination 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). | Other | REFERENCE: white bread |
| TEST: b-glucan enriched breadDetermination 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). | Other | TEST: b-glucan enriched bread |
Primary outcome
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).
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 14 Sep 2017.
- Background: PubMed 19079901Brouns 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.
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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 study chair
Institute of Nutrition, Slovenia (Nutris)
Snežana Kocijančič principal investigator
Institute of Nutrition, Slovenia (Nutris)
Questions about this trial
What is this clinical trial studying?
A study testing REFERENCE: white bread and TEST: b-glucan enriched bread in people with Glycemic Index, run by Institute of Nutrition, Slovenia (Nutris).
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 2 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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)). 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 NCT02543164, which also lists 1 linked publication.
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 14 Sep 2017.