IBSHELFABNCT04677881
Health Effects of Different Types of Bread
A study testing Intervention group in people with IBS, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
Dietary fiber is well known to have health promoting effects, including reduced blood glucose and cholesterol levels. Bread is the most important source of dietary fiber in the Norwegian diet. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS
- What is being tested?
- Intervention group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2020to 31 Dec 2020
- 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
- healthy adults who restrict their intake of bread due to stomach ache.
Who cannot join
- Chronic metabolic diseases, such as diabetes type 1 or 2, cardiovascular diseases and cancer last 6 months
- Gut diseases, including Chron's disease, ulcers colitis
- Food allergies or intolerance
- Pregnant and/or lactating
- Smokers
- BMI <18,5 and >27 kg/m2
Show all 12Show fewer
- Planed weight reduction and/or ± 5% weight change last 3 months
- Blood donor last 2 months and during the study period
- Not willing to quit taking dietary supplements, including probiotics, cod liver oil etc., 4 weeks prior to study start and during the study
- Use of antibiotics <3 months prior to study start and during the study
- Alcohol intake >40 g/day
- Hormone treatment (except contraceptives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Effects and Consumer Aspects of Different Types of Bread
Dietary fiber is well known to have health promoting effects, including reduced blood glucose and cholesterol levels. Bread is the most important source of dietary fiber in the Norwegian diet. Production of bread has changed from the traditionally use of sourdough, to yeast (Saccharomyces cerevisiae) as the dominating leavening agent in modern industrial production. Sourdough naturally contains bacteria, and through the fermentation process these bacteria release several components that are not found in modern bread using yeast. It has been shown that sourdough may have positive health effects, including on blood glucose regulation. The aim of the project is to investigate if intake of sourdough may give positive health effects compared to beard with yeast.
Read the detailed description
The investigators aim to include approximately 20 participants in this randomized controlled double-blind cross-over study lasting for 5 weeks.
All participants will be given bread baked with yeast for a 2 weeks run-in period. The participants will then be randomly assigned to either 1 week intervention with bread baked with yeast or sourdough, before a 1 week wash-out period with yeast bread. During the last 1 week intervention period the participants starting with bread baked with yeast will be given sourdough and vice versa.
Questionnaires (GSRS-IBS, BSC, FFQ), blood samples, and feces samples will be collected before and after the intervention periods.
- Conditions
- IBS
- Being tested
- Intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
intervention group: bread with sourdough control group: bread with yeast
| Study group | Role | What they receive |
|---|---|---|
| Wholegrain bread with yeast | Placebo comparator | The control group will be given min. 5 slices of bread baked with yeast per day. Receives: Other: Intervention group |
| Wholegrain bread with sourdough | Experimental | The experimental group will be given min. 5 slices of bread baked with sourdough per day. Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)
GSRS-IBS analysis after intervention with bread baked with yeast versus sourdough with the following response scale: 1 (no discomfort at all) to 7 (very severe discomfort)
Measured: 5 weeks
Secondary outcomes (4)
Bristol stool chart (BSC)
BSC analyses after intervention with bread baked with yeast versus sourdough with a scale from 1 (separate hard lumps, like nuts) to 7 (watery, no solid pieces)
Measured: 5 weeks
Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids
Blood analyses of C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids after intervention with bread baked with yeast versus sourdough
Measured: 5 weeks
Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)
Feces analyses of microbiota after intervention with bread baked with yeast versus sourdough
Measured: 5 weeks
Iron, selenium and zinc in blood
Blood analysis of iron, selenium and zinc after intervention with bread baked with yeast versus sourdough
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Sep 2020
- Primary completion20 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBSStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Mesterbakeren
- Responsible party
- Sponsor
- Investigators
- Vibeke Telle-Hansen, PhD, Principal investigator, Oslo and Akershus University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677881
- Sponsor's protocol ID
- 96264
- Acronym
- HELFAB
- Status last verified
- Oct 2020
- First submitted
- 26 Nov 2020
- Last updated
- 12 May 2021
- Results posted
- 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects and Consumer Aspects of Different Types of Bread
- ClinicalTrials.gov ID
- NCT04677881
- Acronym / sponsor ID
- HELFAB / 96264
- Conditions
- IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo, Mesterbakeren
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Dec 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.
Dietary fiber is well known to have health promoting effects, including reduced blood glucose and cholesterol levels. Bread is the most important source of dietary fiber in the Norwegian diet. Production of bread has changed from the traditionally use of sourdough, to yeast (Saccharomyces cerevisiae) as the dominating leavening agent in modern industrial production. Sourdough naturally contains bacteria, and through the fermentation process these bacteria release several components that are not found in modern bread using yeast. It has been shown that sourdough may have positive health effects, including on blood glucose regulation. The aim of the project is to investigate if intake of sourdough may give positive health effects compared to beard with yeast.
Detailed description
The investigators aim to include approximately 20 participants in this randomized controlled double-blind cross-over study lasting for 5 weeks.
All participants will be given bread baked with yeast for a 2 weeks run-in period. The participants will then be randomly assigned to either 1 week intervention with bread baked with yeast or sourdough, before a 1 week wash-out period with yeast bread. During the last 1 week intervention period the participants starting with bread baked with yeast will be given sourdough and vice versa.
Questionnaires (GSRS-IBS, BSC, FFQ), blood samples, and feces samples will be collected before and after the intervention periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wholegrain bread with yeast | Placebo comparator | Other: Intervention groupThe control group will be given min. 5 slices of bread baked with yeast per day. |
| Wholegrain bread with sourdough | Experimental | Other: Intervention groupThe experimental group will be given min. 5 slices of bread baked with sourdough per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults who restrict their intake of bread due to stomach ache.
Key exclusion criteria (12 listed)
- Chronic metabolic diseases, such as diabetes type 1 or 2, cardiovascular diseases and cancer last 6 months
- Gut diseases, including Chron's disease, ulcers colitis
- Food allergies or intolerance
- Pregnant and/or lactating
- Smokers
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 |
|---|---|---|
| Intervention groupintervention group: bread with sourdough control group: bread with yeast | Other | Wholegrain bread with sourdough, Wholegrain bread with yeast |
Primary outcome
Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS)
Time frame: 5 weeks
GSRS-IBS analysis after intervention with bread baked with yeast versus sourdough with the following response scale: 1 (no discomfort at all) to 7 (very severe discomfort)
4 secondary outcomes
Bristol stool chart (BSC)
Time frame: 5 weeks
Blood C-peptide, total cholesterol, triglycerides, fatty acid profile, and short chain fatty acids
Time frame: 5 weeks
Feces microbiota analysis performed with Bio-Me's Precision Microbiome Profiling platform (PMP™)
Time frame: 5 weeks
Iron, selenium and zinc in blood
Time frame: 5 weeks
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 12 May 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.
Vibeke Telle-Hansen, PhD principal investigator
Oslo and Akershus University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with IBS, run by Oslo Metropolitan University 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 12 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 12 May 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?
Gastrointestinal Symptom Rating Scale-irritable bowl syndrome (GSRS-IBS) (time frame: 5 weeks). 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 12 May 2021.