Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-01 @ 11:26 PM
Study NCT ID:
NCT05473793
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Dried Vegetable on Bowel Function and Gut Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Subjects not receiving the intervention product will consume a placebo (rice puff particles). Neither the investigator, nor the participants, nor the outcome assessor will know who received what. No Care Provider is included in this trial.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and one control (placebo) arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-22', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bowel function (weekly changes) - bowel function satisfaction', 'timeFrame': 'Weekly development for a period of 4 weeks', 'description': 'Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely"). Compared between different fiber dosages and placebo.'}, {'measure': 'Bowel function (weekly changes) - ease of defecation', 'timeFrame': 'Weekly development for a period of 4 weeks', 'description': 'Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").'}, {'measure': 'Bowel function (weekly changes) - feeling of incomplete bowel emptying', 'timeFrame': 'Weekly development for a period of 4 weeks', 'description': 'Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").'}, {'measure': 'Bowel function (weekly changes) - stool consistency', 'timeFrame': 'Weekly development for a period of 4 weeks', 'description': 'Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).'}, {'measure': 'Bowel function (weekly changes) - stool frequency', 'timeFrame': 'Weekly development for a period of 4 weeks', 'description': 'Stool frequency is measured by counting number of bowel movements per week.'}, {'measure': 'Fecal gut microbiota (weekly changes)', 'timeFrame': 'Weekly development for a period of 4 weeks', 'description': 'Measured in fecal samples using DNA sequencing.'}, {'measure': 'Fecal gut microbiota activity (weekly changes)', 'timeFrame': 'Weekly development for a period of 4 weeks', 'description': 'Fecal gut microbiota activity is determined by measuring microbial metabolites in fecal samples among which fermentation products (short-chain fatty acids) using HPLC.'}], 'primaryOutcomes': [{'measure': 'Bowel function (differences highest dose vs placebo) - bowel function satisfaction', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely").'}, {'measure': 'Bowel function (differences highest dose vs placebo) - ease of defecation', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely").'}, {'measure': 'Bowel function (differences highest dose vs placebo) - feeling of incomplete bowel emptying', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely").'}, {'measure': 'Bowel function (differences highest dose vs placebo) - stool consistency', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea).'}, {'measure': 'Bowel function (differences highest dose vs placebo) - stool frequency', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Stool frequency is measured by counting number of bowel movements per week.'}], 'secondaryOutcomes': [{'measure': 'Fecal gut microbiota (between dose differences)', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Measured in fecal samples using DNA sequencing. Compared between different fiber dosages and placebo.'}, {'measure': 'Fecal gut microbiota activity (between dose differences)', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Fecal gut microbiota activity is determined by measuring microbial metabolites in fecal samples among which fermentation products (short-chain fatty acids) using HPLC. Compared between different fiber dosages and placebo.'}, {'measure': 'Quality of Life (between dose differences)', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Quality of life is measured using the questionnaire Patient Assessment of Constipation - Quality of Life. Compared between different fiber dosages and placebo.'}, {'measure': 'Constipation-related symptoms (between dose differences)', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Constipation symptoms is measured using the questionnaire Patient Assessment of Constipation - Symptoms. Compared between different fiber dosages and placebo.'}, {'measure': 'Bowel function (between dose differences) - bowel function satisfaction', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Bowel function satisfaction is rated on a five-point scale (from "0-not at all" to "4-extremely").\n\nCompared between different fiber dosages and placebo.'}, {'measure': 'Bowel function (between dose differences) - ease of defecation', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Ease of defecation is rated on a five-point scale (from "0-not at all" to "4-extremely"). Compared between different fiber dosages and placebo.'}, {'measure': 'Bowel function (between dose differences) - feeling of incomplete bowel emptying', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Feeling of incomplete bowel emptying is rated on a five-point scale (from "0-not at all" to "4-extremely"). Compared between different fiber dosages and placebo.'}, {'measure': 'Bowel function (between dose differences) - stool consistency', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Stool consistency is measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea). Compared between different fiber dosages and placebo.'}, {'measure': 'Bowel function (between dose differences) - stool frequency', 'timeFrame': 'Change after the intervention of 4 weeks', 'description': 'Stool frequency is measured by counting number of bowel movements per week. Compared between different fiber dosages and placebo.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bowel function issues', 'constipation', 'gut microbiota', 'fiber intake', 'vegetable', 'intrinsic fiber'], 'conditions': ['Bowel Function Dissatisfaction']}, 'referencesModule': {'references': [{'pmid': '32199025', 'type': 'BACKGROUND', 'citation': 'Puhlmann ML, de Vos WM. Back to the Roots: Revisiting the Use of the Fiber-Rich Cichorium intybusL. Taproots. Adv Nutr. 2020 Jul 1;11(4):878-889. doi: 10.1093/advances/nmaa025.'}, {'pmid': '39295776', 'type': 'BACKGROUND', 'citation': 'Puhlmann ML, Jokela R, van Dongen KCW, Bui TPN, van Hangelbroek RWJ, Smidt H, de Vos WM, Feskens EJM. Dried chicory root improves bowel function, benefits intestinal microbial trophic chains and increases faecal and circulating short chain fatty acids in subjects at risk for type 2 diabetes. Gut Microbiome (Camb). 2022 Apr 28;3:e4. doi: 10.1017/gmb.2022.4. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.', 'detailedDescription': 'Background: Bowel function issues can have a substantial effect on quality of life. Additional fiber intake might modulate bowel function and gut microbiota, thereby increasing stool frequency and consistency. This could improve defecation ease, feeling of incomplete bowel emptying and bowel function satisfaction. We hypothesize that a dried vegetable, that is naturally high in fiber within plant cells could improve bowel function in subjects with bowel function issues.\n\nObjective: The main objective of the study is to assess whether a dried multifiber vegetable improves bowel function assessed by stool frequency, consistency, defecation ease, feeling of incomplete bowel emptying and satisfaction. Secondary objectives are to assess whether these effects are dose-dependent and associated with the modulation of the gut microbiota and activity. Furthermore, the adaption of bowel function and adaptation of the gut microbiota and activity over time will be analyzed.\n\nStudy design: A parallel, randomized, double-blind, placebo-controlled trial of four weeks with one placebo control and three intervention arms that differ in intervention product dose.\n\nStudy population: Healthy human volunteers, 20 - 80y old, with bowel function issues reflected in low stool frequency/consistency, difficulty to defecate, and dissatisfaction with their current bowel function.\n\nIntervention: A vegetable product consisting of dried chicory root cubes containing 85% dietary fiber is added to the daily diet. The intervention product is consumed twice daily for four weeks with a maximum dose of 15 g/day. The control (placebo) consists of easily digestible rice puff particles and is consumed in the same manner as the intervention.\n\nMain study parameters/endpoints: Main study outcome are endpoint (week 4) differences from baseline between the highest dose (15 g/day) of the treatment intervention and placebo in bowel function assessed by changes in stool frequency, stool consistency, ease of defecation, incomplete feeling of bowel emptying and bowel function satisfaction. Secondary endpoints are gut microbiota composition and differences in bowel function, quality of life and constipation symptoms assessment between all doses and placebo. Finally, changes over time in gut microbiota and bowel function will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 20 - 80 years old\n* Unsatisfied with bowel functions (self-reported), rated on a visual analogue scale (VAS, 0-10) as less than 6\n* Four or less bowel movements per week (low stool frequency) and/or\n* Hard, lumpy or solid stools (Bristol stool form 1-4) during 90% of bowel movements (hard to solid consistency)\n* Able to read and understand Dutch or English\n\nExclusion Criteria:\n\n* Having a history of medical or surgical events that may significantly affect the study outcome: e.g., IBS or IBD patients and subjects with medically diagnosed constipation (i.e., constipation related to anatomic, medication-related, or readily identifiable physiological causes.)\n* Less than one bowel movement per week during the screening\n* Medical drug use:\n\n * Antibiotic use within 3 months of the study screenings day\n * Chronic use of antacids and PPI's\n * Use of laxatives during the screening\n * Chronic use of blood glucose lowering medication\n* Consumption of supplements containing fibres (other than laxatives), pro-/ post-/ synbiotics 1 month before the screening\n* Not willing to provide faecal samples\n* Unable to comply with proper study procedures\n* For women of childbearing age: current or planned pregnancy, lactation\n* Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.)\n* Reported unexplained weight loss or weight gain of greater than 5 kg in the month prior to pre-study screening\n* Reported slimming or medically prescribed diet\n* Reported macrobiotic lifestyle\n* Personnel the Division of Human Nutrition \\& Health or the Laboratory of Microbiology\n* Current participation in other medical scientific research\n* Not having a general practitioner\n* Not willing to be informed about accidental discoveries in relation to the subjects health"}, 'identificationModule': {'nctId': 'NCT05473793', 'acronym': 'HappYFiber', 'briefTitle': 'Impact of a Dried Vegetable on Bowel Function and Gut Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Impact of a Dried Vegetable on Bowel Function and Gut Microbiota in Subjects With Bowel Function Issues', 'orgStudyIdInfo': {'id': 'NL80274.091.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Highest fiber dose', 'description': 'This arm receives the highest dose of the intervention product, which is 15g dried vegetable per day divided into two portions of each 7.5g, which are consumed during the course of the day in the food of choice.', 'interventionNames': ['Dietary Supplement: Dried chicory root particles']}, {'type': 'EXPERIMENTAL', 'label': 'Medium fiber dose', 'description': 'This arm receives the highest dose of the intervention product, which is 10g dried vegetable per day divided into two portions of each 5.0g, which are consumed during the course of the day in the food of choice.', 'interventionNames': ['Dietary Supplement: Dried chicory root particles']}, {'type': 'EXPERIMENTAL', 'label': 'Lowest fiber dose', 'description': 'This arm receives the highest dose of the intervention product, which is 5g dried vegetable per day divided into two portions of each 2.5g, which are consumed during the course of the day in the food of choice.', 'interventionNames': ['Dietary Supplement: Dried chicory root particles']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'This arm is the control arm receiving as placebo rice puff particles each day, whose amount corresponds iso-calorically to the medium fiber dosage (\\~ 21 kcal/day).', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dried chicory root particles', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['brand name: WholeFiber™'], 'description': 'The intervention product consists of chicory root that have been sliced and dried and are provided in the form of particles (\\~3mm).', 'armGroupLabels': ['Highest fiber dose', 'Lowest fiber dose', 'Medium fiber dose']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Rice puff particles'], 'description': 'The control arm receives a placebo consisting of rice puff particles.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6708 WE', 'city': 'Wageningen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sofie CC van der Zalm, MSc', 'role': 'CONTACT', 'email': 'sofie.vanderzalm@wur.nl', 'phone': '+31 6 18 41 71 62'}, {'name': 'Marie-Luise Puhlmann, MSc', 'role': 'CONTACT', 'email': 'marie-luise.puhlmann@wur.nl', 'phone': '+31 6 38 03 11 29'}, {'name': 'Edith JM Feskens, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wageningen University & Research, Division of Human Nutrition & Health', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'centralContacts': [{'name': 'Edith JM Feskens, Prof. dr', 'role': 'CONTACT', 'email': 'edith.feskens@wur.nl', 'phone': '+31317482567'}, {'name': 'Sofie CC van der Zalm, MSc', 'role': 'CONTACT', 'email': 'vezel@wur.nl', 'phone': '+31618417162'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As the data contains sensitive personal information researchers interested in the data can contact the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'WholeFiber BV', 'class': 'UNKNOWN'}, {'name': 'Wageningen University and Research, Laboratory of Microbiology', 'class': 'UNKNOWN'}, {'name': 'Wageningen University and Research, Division of Human Nutrition & Health', 'class': 'UNKNOWN'}, {'name': 'Wageningen University and Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. Edith Feskens', 'investigatorFullName': 'Edith Feskens', 'investigatorAffiliation': 'Wageningen University'}}}}