Postprandial HyperglycemiaNCT04289545
Postprandial Effects of Functional Bread
A study testing Functional bread in people with Postprandial Hyperglycemia, run by University of Bergen at 1 site in Norway.
Trial summary
This study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Functional bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2019to 7 Jul 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, overweight adults (BMI between 25 and 30 kg/m2)
Who cannot join
- Known diagnosis of diabetes mellitus type 2
- HbA1c at screening ≥ 48 mmol/mol
- Other chronic diseases (heart disease, cancer) within the last 3 years
- Pregnancy and lactation
- Known drug or alcohol abuse
- Unwilling to follow the study requirements
Trial locations and contacts
1 site in 1 country.
Norway1 site
University of Bergen, Research Unit for Health Surveys
Bergen, 5020
About this study
This study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults.
Read the detailed description
This single-blind crossover-designed study wants to investigate the postprandial effect of functional bread in healthy overweight adults. Therefore, four types of bread, consumed by the participants, have added galactomannan in different amounts and viscosities, and one bread is the control bread.
The participants arrive after an overnight fast and before the consumption of bread, a fasting blood sample is taken.
After the ingestion, blood samples are taken at specific times. The area under the curve of the postprandial glucose is expected to differ between the functional breads.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- Functional bread
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional breadDietary supplement
Postprandial effects of bread containing galactomannan
| Study group | Role | What they receive |
|---|---|---|
| Control Bread | Placebo comparator | no added guar gum Receives: Dietary Supplement: Functional bread |
| Functional Bread 1 | Active comparator | 10% guar gum, low molecular weight Receives: Dietary Supplement: Functional bread |
| functional Bread 2 | Active comparator | 10% guar gum, high molecular weight Receives: Dietary Supplement: Functional bread |
| Functional Bread 3 | Active comparator | 15% guar gum, low molecular weight Receives: Dietary Supplement: Functional bread |
| Functional Bread 4 | Active comparator | 15% guar gum, high molecular weight Receives: Dietary Supplement: Functional bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve of postprandial glucose
Measured: 180 minutes
Secondary outcomes (1)
area under the curve postprandial insulin
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Nov 2019
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial HyperglycemiaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jutta Dierkes, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289545
- Sponsor's protocol ID
- 11367/2019
- Status last verified
- Jul 2021
- First submitted
- 26 Feb 2020
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Effects of Functional Bread
- ClinicalTrials.gov ID
- NCT04289545
- Acronym / sponsor ID
- 11367/2019
- Conditions
- Postprandial Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 28 Feb 2020 (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.
This study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults.
Detailed description
This single-blind crossover-designed study wants to investigate the postprandial effect of functional bread in healthy overweight adults. Therefore, four types of bread, consumed by the participants, have added galactomannan in different amounts and viscosities, and one bread is the control bread.
The participants arrive after an overnight fast and before the consumption of bread, a fasting blood sample is taken.
After the ingestion, blood samples are taken at specific times. The area under the curve of the postprandial glucose is expected to differ between the functional breads.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Bread | Placebo comparator | Dietary Supplement: Functional breadno added guar gum |
| Functional Bread 1 | Active comparator | Dietary Supplement: Functional bread10% guar gum, low molecular weight |
| functional Bread 2 | Active comparator | Dietary Supplement: Functional bread10% guar gum, high molecular weight |
| Functional Bread 3 | Active comparator | Dietary Supplement: Functional bread15% guar gum, low molecular weight |
| Functional Bread 4 | Active comparator | Dietary Supplement: Functional bread15% guar gum, high molecular weight |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, overweight adults (BMI between 25 and 30 kg/m2)
Key exclusion criteria (6 listed)
- Known diagnosis of diabetes mellitus type 2
- HbA1c at screening ≥ 48 mmol/mol
- Other chronic diseases (heart disease, cancer) within the last 3 years
- Pregnancy and lactation
- Known drug or alcohol abuse
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 |
|---|---|---|
| Functional breadPostprandial effects of bread containing galactomannan | Dietary supplement | Control Bread, Functional Bread 1, Functional Bread 3, Functional Bread 4, functional Bread 2 |
Primary outcome
area under the curve of postprandial glucose
Time frame: 180 minutes
1 secondary outcome
area under the curve postprandial insulin
Time frame: 180 minutes
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 Jul 2021.
- 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.
Jutta Dierkes, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional bread in people with Postprandial Hyperglycemia, run by University of Bergen at 1 site in Norway.
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 1 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 Jul 2021. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
area under the curve of postprandial glucose (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2021.