Non-celiac Gluten SensitivityNCT04401956
Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread
A study testing bread in people with Non-celiac Gluten Sensitivity and Wheat Intolerance, run by University of Hohenheim at 1 site in Germany.
Trial summary
This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-celiac Gluten Sensitivity, Wheat Intolerance
- What is being tested?
- bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2020to 7 Sep 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 ≤70 years
- Signed declaration of consent
- Willingness to adhere to the prescribed diet for the duration of the study
- Subjective bread wheat intolerance
- No known spelled intolerance
- No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
- No participation in another clinical trial (current or within the past 30 days)
- Gluten-containing diet at least 6 weeks before the start of the study
Who cannot join
- Taking intestinal therapeutics, antibiotics, immunosuppressants or similar
- Pregnancy / lactation
- Relevant violations of the nutritional protocol
- Occurrence of relevant diseases (possibly individual decision)
- Revocation of consent
- Accommodation in a clinic or similar facility based on an official or judicial order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Tolerance of Spelt and Wheat Bread in Humans With Suspected NCWS Considering Different Manufacturing Processes of Bread
This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered.
Read the detailed description
Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The prevalence of both diseases is about 1%. Recently, another clinical entity was described, the non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. Three different grain components have been proposed as triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (FODMAPs).
It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. Therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. So far, human study addressing such questions are lacking.
This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes on wheat sensitivity will be revealed.
For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. Aim of this part is to objective bread wheat and spelt intolerance in a defined population. To find out whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs.
- Conditions
- Non-celiac Gluten Sensitivity, Wheat Intolerance
- Being tested
- bread
- Keywords
- Human Nutrition, NCWS, Spelt, Wheat Bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breadOther
Different types of bread
| Study group | Role | What they receive |
|---|---|---|
| Gluten free bread with added gluten | Active comparator | Bread will be eaten by the participants for 4 consecutive days. Receives: Other: bread |
| Gluten free bread with added FODMAPs | Active comparator | Bread will be eaten by the participants for 4 consecutive days. Receives: Other: bread |
| Traditional manufactured wheat bread | Experimental | Bread will be eaten by the participants for 4 consecutive days. Receives: Other: bread |
| Traditional manufactured spelt bread | Experimental | Bread will be eaten by the participants for 4 consecutive days. Receives: Other: bread |
| Conventional manufactured wheat bread | Experimental | Bread will be eaten by the participants for 4 consecutive days. Receives: Other: bread |
| Conventional manufactured spelt bread | Experimental | Bread will be eaten by the participants for 4 consecutive days. Receives: Other: bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IBS-SSS Total score
IBS-SSS Total score will be collected with a questionnaire
Measured: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
Secondary outcomes (2)
Extraintestinal Symptoms
The study team will ask the participants for typical extraintestinal symptoms in NCWS like headache, foggy-mind, nausea, heartburn, exhaustion
Measured: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
Blood and fecal markers
Change of blood- and fecal markers that will reveal inflammation or intestinal permeability (Anti-gliadin Immunglobulin G antibody, lipase, ferritin, zonulin, calprotectin and lactoferrin)
Measured: Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start15 May 2020
- Primary completion10 Aug 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-celiac Gluten SensitivityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401956
- Sponsor's protocol ID
- ErnMed-Brot
- Status last verified
- Oct 2021
- First submitted
- 14 May 2020
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Tolerance of Spelt and Wheat Bread in Humans With Suspected NCWS Considering Different Manufacturing Processes of Bread
- ClinicalTrials.gov ID
- NCT04401956
- Acronym / sponsor ID
- ErnMed-Brot
- Conditions
- Non-celiac Gluten Sensitivity, Wheat Intolerance
- Keywords
- Human Nutrition, NCWS, Spelt, Wheat Bread
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 26 May 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 project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes will be considered.
Detailed description
Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The prevalence of both diseases is about 1%. Recently, another clinical entity was described, the non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at present, but the existence of this new disease entity has been proven by double-blind placebo-controlled challenge tests. Three different grain components have been proposed as triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates (FODMAPs).
It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products much better, even though spelt shows a higher gluten content than bread wheat products. Therefore, the question arises whether this putative spelt tolerance can be confirmed on an objective basis and whether the underlying molecular mechanisms can be elucidated. So far, human study addressing such questions are lacking.
This project aims to verify the hypothesis that spelt products are more tolerable than bread wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In addition, the influence of different manufacturing processes on wheat sensitivity will be revealed.
For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt breads, each of them produced following a traditional or a conventional way. Aim of this part is to objective bread wheat and spelt intolerance in a defined population. To find out whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Gluten free bread with added gluten | Active comparator | Other: breadBread will be eaten by the participants for 4 consecutive days. |
| Gluten free bread with added FODMAPs | Active comparator | Other: breadBread will be eaten by the participants for 4 consecutive days. |
| Traditional manufactured wheat bread | Experimental | Other: breadBread will be eaten by the participants for 4 consecutive days. |
| Traditional manufactured spelt bread | Experimental | Other: breadBread will be eaten by the participants for 4 consecutive days. |
| Conventional manufactured wheat bread | Experimental | Other: breadBread will be eaten by the participants for 4 consecutive days. |
| Conventional manufactured spelt bread | Experimental | Other: breadBread will be eaten by the participants for 4 consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 ≤70 years
- Signed declaration of consent
- Willingness to adhere to the prescribed diet for the duration of the study
- Subjective bread wheat intolerance
- No known spelled intolerance
Key exclusion criteria (6 listed)
- Taking intestinal therapeutics, antibiotics, immunosuppressants or similar
- Pregnancy / lactation
- Relevant violations of the nutritional protocol
- Occurrence of relevant diseases (possibly individual decision)
- Revocation of consent
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 |
|---|---|---|
| breadDifferent types of bread | Other | Conventional manufactured spelt bread, Conventional manufactured wheat bread, Gluten free bread with added FODMAPs, Gluten free bread with added gluten, Traditional manufactured spelt bread, Traditional manufactured wheat bread |
Primary outcome
Change of IBS-SSS Total score
Time frame: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
IBS-SSS Total score will be collected with a questionnaire
2 secondary outcomes
Extraintestinal Symptoms
Time frame: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)
Blood and fecal markers
Time frame: Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).
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 27 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Non-celiac Gluten Sensitivity
Recruiting
Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity
Non-celiac Gluten/Wheat Sensitivity
Recruiting
Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity
Non-celiac Gluten Sensitivity
Not yet recruiting
Inflammatory Back Pain and Gluten Free Diet
Inflammatory Back Pain
RecruitingObservational study
Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Familial Mediterranean Fever, Non-celiac Gluten Sensitivity
Recruiting
Bio-markers of Not-celiac Wheat Sensitivity
Not-celiac Wheat Sensitivity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bread in people with Non-celiac Gluten Sensitivity and Wheat Intolerance, run by University of Hohenheim at 1 site in Germany.
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 8 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 27 Oct 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 Germany. 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 of IBS-SSS Total score (time frame: Study examinations are at baseline, after wash out phases (day 3, 10, 17, 24, 31, 38) and after bread intervention phases (day 7, 14, 21, 28, 35, 42).)). 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 27 Oct 2021.