Non Coeliac Gluten SensitivityNCT02308397
Bakery Products for Non-Coeliac Gluten Sensitive Consumers
A study testing Normal gluten containing bread, Bread with reduced gliadins content and Bread with reduced ATIs content in people with Non Coeliac Gluten Sensitivity, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The aim of the study is to produce a tolerable alternative to normal wheat bread which would be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread would be made from wheat so, in contrast to gluten-free bread, would be more comparable to standard bread. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Coeliac Gluten Sensitivity
- What is being tested?
- Normal gluten containing bread, Bread with reduced gliadins content and Bread with reduced ATIs content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Mar 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female, aged 18-70, who believe they experience non-coeliac gluten sensitivity
Who cannot join
- Medical exclusion criteria
- Coeliac Disease
- Wheat allergy
- Dermatitis Herpetiformis
- Gastrointestinal disorders: Small Intestinal Bowel Overgrowth (SIBO), Crohn's disease , Ulcerative Colitis, Inflammatory Bowel Disease (IBD)
- History of gastrointestinal surgery/procedure over the last 3 years
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- Kidney disease
- Hepatic disease
- Active cancer
- Severe cardiovascular disease
- Addiction to any substances
- Breastfeeding/ Pregnancy
- Volunteers with poorly controlled psychiatric disease or those unable to give written informed consent will also be excluded.
- Medication exclusion criteria
- Medications for treatment of heartburn, dyspepsia, indigestion, bloating etc. e.g. gastrokinetics or prokinetics, antacids, laxatives
- Digestive enzymes
Trial locations and contacts
1 site in 1 country.
Nigel Dr Hoggard, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Aberdeen Rowett Institute of Nutrition and Health
Aberdeen, AB21 9SB
Nigel Hoggard, PhD, 0044 (0)1224 438655, N.Hoggard@abdn.ac.uk
Dinka Rees, 0044 (0)1224 438602, dinka.rees@abdn.ac.uk
About this study
The aim of the study is to produce a tolerable alternative to normal wheat bread which would be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread would be made from wheat so, in contrast to gluten-free bread, would be more comparable to standard bread. To make this bread, the investigators will use advanced enzyme technology and/or novel formulations to target the digestion or removal of wheat proteins, which might be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other those that are more useful for baking quality. The investigators will determine palatability and tolerance of this new product in a human cross-over, randomised, blind and placebo-controlled intervention study.
It has been estimated 6-10% of the population are sensitive to gluten who do not have coeliac disease (CD). Three breads will be produced and tested in this study against a suitable reference based on standard wheat flour and baking process
Read the detailed description
Prior to the study each volunteer will undergo screening procedure (Health Screening Questionnaire) for compliance with the inclusion/exclusion criteria. The volunteers who meet those criteria will be invited to sign an informed consent. Following this the volunteers will be asked to complete:
- Gluten Sensitivity Questionnaire
- SF-36 Quality of Life Questionnaire
- Beacke Physical Activity Questionnaire
- DASS 21 Questionnaire
It is anticipated that NCGS volunteers are following a low gluten or gluten-free life style. Evaluation of their dietary compliance with gluten-free diet will be done through using numerical scores (Biagi at al.,2009) - a system based on strategies that the subjects use to avoid eating gluten.
Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of overall abdominal symptoms, abdominal pain, bloating, wind, satisfaction with stool consistency, tiredness, and nausea.
Severity of fatigue will be evaluated by the Daily-Fatigue Impact Scale (D-FIS), a questionnaire containing 8 items that evaluates the impact of fatigue on cognition, physical functioning, and daily activities.
After one week of a baseline period, the subjects will be assigned to one week of dietary intervention (bread A, B, C or D), followed by 14-day wash-out period before crossing over to the next bread. All volunteers will be randomised to all four groups/cross over intervention.
Treatment:
- Bread A - normal (gluten-containing) reference bread
- Bread B - bread with reduced gliadin content
- Bread C - bread with reduced ATIs
- Bread D - bread with reduced overall protein content
Each treatment bread will be consumed for one week (3 slices per day), followed by washout period of at least 2 weeks or until symptoms induced during the previous dietary challenge resolved. Volunteers unable to continue a treatment due to intolerable symptoms will be permitted to cease the study food of that particular arm but can continue if they wish with the study.
Bread will be provided to volunteers at the beginning of each treatment week. Compliance will be determined with questioning at time of review and counting the slices of bread left at the end of the treatment week.
Pilot study
For volunteers only recruited from the Aberdeen and the Aberdeenshire area as part of a pilot study we will also ask volunteers to make a single visit (at the beginning of the study) to the RINH. At this visit a fasting blood sample will be taken, the blood pressure will be checked and anthropometric measurements will be made.
Blood test:
- IgA anti-tissue transglutaminase antibody and total IgA level.
- IgA endomysial antibody
- IgG deamidated gliadin peptide antibodies (DGP-AGA)
- Immunoglobulin IgG/IgA antigliadin antibodies (AGA)
- Flow cytometric basophil activation test
- Gliadin-specific T cells in the peripheral blood
- Full blood count
- Lipid profile
- Vit B12 and folic acid status
- Conditions
- Non Coeliac Gluten Sensitivity
- Being tested
- Normal gluten containing bread, Bread with reduced gliadins content, Bread with reduced ATIs content, Bread with reduced overall protein content
- Keywords
- non coeliac gluten sensitivity, gluten, bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal gluten containing breadOther
Group 1 will begin with Normal gluten containing bread(A) and then move to bread B,C and D
Bread with reduced gliadins contentOther
Group 2 will begin with Bread with reduced gliadins content (B) and then move to bread A, C and D
Bread with reduced ATIs contentOther
Group 3 will begin with Bread with reduced ATIs content (C) and then move to bread A, B and D
Bread with reduced overall protein contentOther
Group 4 will begin with Bread with reduced overall protein content (D) d then move to bread A, B and C
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Begins with Normal gluten containing bread Receives: Other: Normal gluten containing bread |
| Group 2 | Experimental | Begins with Bread with reduced gliadins content Receives: Other: Bread with reduced gliadins content |
| Group 3 | Experimental | Begins with Bread with reduced ATIs content Receives: Other: Bread with reduced ATIs content |
| Group 4 | Experimental | Begins with Bread with reduced overall protein content Receives: Other: Bread with reduced overall protein content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score)
Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of abdominal pain, bloating, wind and nausea.
Measured: These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)
Secondary outcomes (1)
Change in the presence and severity of daily fatigue (Daily-Fatigue Impact Scale (D-FIS)
Severity of fatigue will be evaluated by the Daily-Fatigue Impact Scale (D-FIS), a questionnaire containing 8 items that evaluates the impact of fatigue on cognition, physical functioning, and daily activities.
Measured: Fatigue will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
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 Non Coeliac 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308397
- Sponsor's protocol ID
- Rowett 904
- Status last verified
- Oct 2017
- First submitted
- 13 Nov 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Rees D, Holtrop G, Chope G, Moar KM, Cruickshank M, Hoggard N. A randomised, double-blind, cross-over trial to evaluate bread, in which gluten has been pre-digested by prolyl endoprotease treatment, in subjects self-reporting benefits of adopting a gluten-free or low-gluten diet. Br J Nutr. 2018 Mar;119(5):496-506. doi: 10.1017/S0007114517003749.
PubMed 29508689
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bakery Products for Non-Coeliac Gluten Sensitive Consumers
- ClinicalTrials.gov ID
- NCT02308397
- Acronym / sponsor ID
- Rowett 904
- Conditions
- Non Coeliac Gluten Sensitivity
- Keywords
- non coeliac gluten sensitivity, gluten, bread
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 4 Dec 2014 (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.
The aim of the study is to produce a tolerable alternative to normal wheat bread which would be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread would be made from wheat so, in contrast to gluten-free bread, would be more comparable to standard bread. To make this bread, the investigators will use advanced enzyme technology and/or novel formulations to target the digestion or removal of wheat proteins, which might be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other those that are more useful for baking quality. The investigators will determine palatability and tolerance of this new product in a human cross-over, randomised, blind and placebo-controlled intervention study.
It has been estimated 6-10% of the population are sensitive to gluten who do not have coeliac disease (CD). Three breads will be produced and tested in this study against a suitable reference based on standard wheat flour and baking process
Detailed description
Prior to the study each volunteer will undergo screening procedure (Health Screening Questionnaire) for compliance with the inclusion/exclusion criteria. The volunteers who meet those criteria will be invited to sign an informed consent. Following this the volunteers will be asked to complete:
- Gluten Sensitivity Questionnaire
- SF-36 Quality of Life Questionnaire
- Beacke Physical Activity Questionnaire
- DASS 21 Questionnaire
It is anticipated that NCGS volunteers are following a low gluten or gluten-free life style. Evaluation of their dietary compliance with gluten-free diet will be done through using numerical scores (Biagi at al.,2009) - a system based on strategies that the subjects use to avoid eating gluten.
Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of overall abdominal symptoms, abdominal pain, bloating, wind, satisfaction with stool consistency, tiredness, and nausea.
Severity of fatigue will be evaluated by the Daily-Fatigue Impact Scale (D-FIS), a questionnaire containing 8 items that evaluates the impact of fatigue on cognition, physical functioning, and daily activities.
After one week of a baseline period, the subjects will be assigned to one week of dietary intervention (bread A, B, C or D), followed by 14-day wash-out period before crossing over to the next bread. All volunteers will be randomised to all four groups/cross over intervention.
Treatment:
- Bread A - normal (gluten-containing) reference bread
- Bread B - bread with reduced gliadin content
- Bread C - bread with reduced ATIs
- Bread D - bread with reduced overall protein content
Each treatment bread will be consumed for one week (3 slices per day), followed by washout period of at least 2 weeks or until symptoms induced during the previous dietary challenge resolved. Volunteers unable to continue a treatment due to intolerable symptoms will be permitted to cease the study food of that particular arm but can continue if they wish with the study.
Bread will be provided to volunteers at the beginning of each treatment week. Compliance will be determined with questioning at time of review and counting the slices of bread left at the end of the treatment week.
Pilot study
For volunteers only recruited from the Aberdeen and the Aberdeenshire area as part of a pilot study we will also ask volunteers to make a single visit (at the beginning of the study) to the RINH. At this visit a fasting blood sample will be taken, the blood pressure will be checked and anthropometric measurements will be made.
Blood test:
- IgA anti-tissue transglutaminase antibody and total IgA level.
- IgA endomysial antibody
- IgG deamidated gliadin peptide antibodies (DGP-AGA)
- Immunoglobulin IgG/IgA antigliadin antibodies (AGA)
- Flow cytometric basophil activation test
- Gliadin-specific T cells in the peripheral blood
- Full blood count
- Lipid profile
- Vit B12 and folic acid status
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Normal gluten containing breadBegins with Normal gluten containing bread |
| Group 2 | Experimental | Other: Bread with reduced gliadins contentBegins with Bread with reduced gliadins content |
| Group 3 | Experimental | Other: Bread with reduced ATIs contentBegins with Bread with reduced ATIs content |
| Group 4 | Experimental | Other: Bread with reduced overall protein contentBegins with Bread with reduced overall protein content |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female, aged 18-70, who believe they experience non-coeliac gluten sensitivity
Key exclusion criteria (16 listed)
- Medical exclusion criteria
- Volunteers with poorly controlled psychiatric disease or those unable to give written informed consent will also be excluded.
- Medication exclusion criteria
- Medications for treatment of heartburn, dyspepsia, indigestion, bloating etc. e.g. gastrokinetics or prokinetics, antacids, laxatives
- Digestive enzymes
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 |
|---|---|---|
| Normal gluten containing breadGroup 1 will begin with Normal gluten containing bread(A) and then move to bread B,C and D | Other | Group 1 |
| Bread with reduced gliadins contentGroup 2 will begin with Bread with reduced gliadins content (B) and then move to bread A, C and D | Other | Group 2 |
| Bread with reduced ATIs contentGroup 3 will begin with Bread with reduced ATIs content (C) and then move to bread A, B and D | Other | Group 3 |
| Bread with reduced overall protein contentGroup 4 will begin with Bread with reduced overall protein content (D) d then move to bread A, B and C | Other | Group 4 |
Primary outcome
Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score)
Time frame: These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)
Gastrointestinal symptoms will be assessed by the participant completing daily diary cards via a 100-mm VAS to score the presence and severity of abdominal pain, bloating, wind and nausea.
1 secondary outcome
Change in the presence and severity of daily fatigue (Daily-Fatigue Impact Scale (D-FIS)
Time frame: Fatigue will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 29508689Rees D, Holtrop G, Chope G, Moar KM, Cruickshank M, Hoggard N. A randomised, double-blind, cross-over trial to evaluate bread, in which gluten has been pre-digested by prolyl endoprotease treatment, in subjects self-reporting benefits of adopting a gluten-free or low-gluten diet. Br J Nutr. 2018 Mar;119(5):496-506. doi: 10.1017/S0007114517003749.
- Individual participant dataSharing planned: Undecided
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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.
Nigel Dr Hoggard, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal gluten containing bread, Bread with reduced gliadins content and Bread with reduced ATIs content in people with Non Coeliac Gluten Sensitivity, run by University of Aberdeen at 1 site in United Kingdom.
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 16 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: status not confirmed, as of the sponsor's last update on 27 Oct 2017. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nigel Dr Hoggard, PhD (n.hoggard@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score) (time frame: These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9)). 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 NCT02308397, 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 27 Oct 2017.