Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-06 @ 8:15 PM
Study NCT ID:
NCT04590768
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2020-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D004043', 'term': 'Dietary Fiber'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-18', 'studyFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gastro intestinal (GI) complaints', 'timeFrame': 'Daily, during 18 days of Fermotein™ intake and up to three days after intake.', 'description': 'Determined by combining multiple outcome measures ( bloated feeling, belching, abdominal pain, flatulence, nausea, diarrhoea, constipation) measured via questionnaires with Visual Analogue Scale (VAS) scores; from no complaints (minimal) to serious complaints (maximum). Higher values represent a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'change in blood hemoglobin', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood Fe (iron)', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood ferritin', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood insulin', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood glucose', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood cholesterol (total)', 'timeFrame': 'before and after 18 days consumption of Fermotein™ or control product', 'description': 'under fasting conditions'}, {'measure': 'change in blood ALAT', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood ASAT', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood GGT', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood leukocyte cell counts', 'timeFrame': 'at baseline, and after 18 days of fermotein or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood creatinine', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood zonulin', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'under fasting conditions'}, {'measure': 'change in blood pressure', 'timeFrame': 'at baseline, and after 18 days of Fermotein™ or control product consumption', 'description': 'systolic and diastolic bloodpressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fermotein™', 'Gastrointestinal tolerance'], 'conditions': ['Gastrointestinal Complication']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on gastrointestinal complaints and several other health related biomarkers. Furthermore, consumer acceptance is investigated. The study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals and a 18-day intervention with control meals. At the start and at the end of the intervention, a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.', 'detailedDescription': 'Fermotein™ is a mycoprotein, derived from fungi, especially produced for human consumption. It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Its functional properties and nutrient content makes them ideal to use as an ingredient for meat alternatives and other vegetarian/vegan food products. This study aims to assess the impact of frequent intake of 11 grams of Fermotein™ powder (dry) on gastrointestinal complaints and several other health related biomarkers.\n\nThe primary objective is to investigate gastro-intestinal complaints during 18 days of Fermotein™ consumption. The secondary objective is to assess blood based parameters related to general health and consumer acceptance.\n\nThe study has a randomized parallel design. Two different treatments will be evaluated e.g. a 18-day intervention with Fermotein™ based meals and a 18-day intervention with control meals. At the start and at the end of the intervention a blood sample will be collected. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Apparently healthy men and women (based on questionnaire)\n* Age between 18 and 70 years\n* Body mass index (BMI) between 18.5 and 29.9 kg/m2\n\nExclusion criteria:\n\n* Any metabolic, gastrointestinal, inflammatory or chronic disease (such as diabetes, anaemia, hepatitis, cardiovascular disease), judged by the medical doctor\n* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints\n* History of liver dysfunction (cirrhosis, hepatitis)\n* Kidney dysfunction (self reported)\n* Use of medication that may influence the study results, such as gastric acid inhibitors or laxatives\n* Reported slimming or medically prescribed diet\n* Current smokers\n* Alcohol intake over 4 glasses of alcoholic beverages per day\n* Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported)\n* Abuse of illicit drugs\n* Having food allergies\n* Participation in another clinical trial at the same time\n* Being an employee of the department Consumer Science and Health group of Wageningen Food and Biobased Research'}, 'identificationModule': {'nctId': 'NCT04590768', 'briefTitle': 'Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University and Research'}, 'officialTitle': 'Tolerance of Regular Meal Intake With Mycoprotein', 'orgStudyIdInfo': {'id': 'NL72349.081.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fermotein™', 'description': 'daily lunch with 11 grams of Fermotein™ dry powder, mixed in bread, soup or a burger', 'interventionNames': ['Other: Fermotein based meals']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Matched control products', 'description': 'daily lunch with a control bread matched in macronutrient content. Control meat alternative burgers and soup from the local supermarket.', 'interventionNames': ['Other: Matching control meals with whey protein and wheat bran']}], 'interventions': [{'name': 'Fermotein based meals', 'type': 'OTHER', 'description': 'various meal products: bread, soup and an occasional burgers', 'armGroupLabels': ['Fermotein™']}, {'name': 'Matching control meals with whey protein and wheat bran', 'type': 'OTHER', 'description': 'various meal products: bread, soup and an occasional burgers', 'armGroupLabels': ['Matched control products']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6708 WG', 'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Stichting Wageningen Research', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Diederik Esser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University and Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University and Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Protein Brewery', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Diederik Esser', 'investigatorAffiliation': 'Wageningen University and Research'}}}}