Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT04401956
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2020-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001939', 'term': 'Bread'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of IBS-SSS Total score', 'timeFrame': '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).)', 'description': 'IBS-SSS Total score will be collected with a questionnaire'}], 'secondaryOutcomes': [{'measure': 'Extraintestinal Symptoms', 'timeFrame': '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).)', 'description': 'The study team will ask the participants for typical extraintestinal symptoms in NCWS like headache, foggy-mind, nausea, heartburn, exhaustion'}, {'measure': 'Blood and fecal markers', 'timeFrame': 'Study examinations are at baseline and after bread intervention phases (day 7, 14, 21, 28, 35, 42).', 'description': 'Change of blood- and fecal markers that will reveal inflammation or intestinal permeability (Anti-gliadin Immunglobulin G antibody, lipase, ferritin, zonulin, calprotectin and lactoferrin)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Nutrition', 'NCWS', 'Spelt', 'Wheat Bread'], 'conditions': ['Non-celiac Gluten Sensitivity', 'Wheat Intolerance']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nIt 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.\n\nThis 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 ≤70 years\n* Signed declaration of consent\n* Willingness to adhere to the prescribed diet for the duration of the study\n* Subjective bread wheat intolerance\n* No known spelled intolerance\n* No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)\n* No participation in another clinical trial (current or within the past 30 days)\n* Gluten-containing diet at least 6 weeks before the start of the study\n\nExclusion Criteria:\n\n* Taking intestinal therapeutics, antibiotics, immunosuppressants or similar\n* Pregnancy / lactation\n* Relevant violations of the nutritional protocol\n* Occurrence of relevant diseases (possibly individual decision)\n* Revocation of consent\n* Accommodation in a clinic or similar facility based on an official or judicial order'}, 'identificationModule': {'nctId': 'NCT04401956', 'briefTitle': 'Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread', 'organization': {'class': 'OTHER', 'fullName': 'University of Hohenheim'}, 'officialTitle': 'Comparison of the Tolerance of Spelt and Wheat Bread in Humans With Suspected NCWS Considering Different Manufacturing Processes of Bread', 'orgStudyIdInfo': {'id': 'ErnMed-Brot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gluten free bread with added gluten', 'description': 'Bread will be eaten by the participants for 4 consecutive days.', 'interventionNames': ['Other: bread']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gluten free bread with added FODMAPs', 'description': 'Bread will be eaten by the participants for 4 consecutive days.', 'interventionNames': ['Other: bread']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional manufactured wheat bread', 'description': 'Bread will be eaten by the participants for 4 consecutive days.', 'interventionNames': ['Other: bread']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional manufactured spelt bread', 'description': 'Bread will be eaten by the participants for 4 consecutive days.', 'interventionNames': ['Other: bread']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional manufactured wheat bread', 'description': 'Bread will be eaten by the participants for 4 consecutive days.', 'interventionNames': ['Other: bread']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional manufactured spelt bread', 'description': 'Bread will be eaten by the participants for 4 consecutive days.', 'interventionNames': ['Other: bread']}], 'interventions': [{'name': 'bread', 'type': 'OTHER', 'description': 'Different types of bread', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70599', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'University of Hohenheim', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hohenheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med.', 'investigatorFullName': 'Stephan C. Bischoff, MD, Professor', 'investigatorAffiliation': 'University of Hohenheim'}}}}