Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT02957318
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Potato Fiber on Appetite and Fecal Fat Excretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045602', 'term': 'Steatorrhea'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal fat excretion', 'timeFrame': 'Based on total feces collection the last 3 days of the 21-day intervention periods'}, {'measure': 'Subjective appetite sensations', 'timeFrame': 'Assessed on 3-hour meal test on last day of the 21-day intervention periods', 'description': 'Assessed by visual analogue scales (VAS)'}], 'secondaryOutcomes': [{'measure': 'Ad libitum energy intake', 'timeFrame': 'Assessed 3 hours after intake of the test meal on last day of the 21-day intervention periods'}, {'measure': 'Fecal energy excretion', 'timeFrame': 'Measured based on total feces collection the last 3 days of the 21-day intervention periods'}, {'measure': 'Blood lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides)', 'timeFrame': 'Measured before and after the 21-day intervention periods'}, {'measure': 'Insulin and glucose', 'timeFrame': 'Measured before and after the 21-day intervention periods, and every 30 minutes during the 3-hour meal test on last day of the 21-week intervention periods'}, {'measure': 'Gut permeability marker', 'timeFrame': 'Measured before and after the 21-day intervention periods'}, {'measure': 'Gastric emptying rate (w. paracetamol)', 'timeFrame': 'Measured every 30 minutes during the 3-hour meal test on last day of the 21-day intervention periods'}, {'measure': 'Gastrointestinal symptoms (questionnaire)', 'timeFrame': 'on day 1, 7, 14 and 22 of the 21-day intervention periods'}, {'measure': 'Body weight', 'timeFrame': 'up to 21-day intervention periods'}, {'measure': 'Blood pressure', 'timeFrame': 'up to 21-day intervention periods'}, {'measure': 'Breath hydrogen', 'timeFrame': 'up to 21-day intervention periods'}, {'measure': 'Gut microbiota', 'timeFrame': 'Measured in a fresh feces sample from day 19-21 of the intervention periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fecal Fat Increased', 'Obesity', 'Appetite']}, 'descriptionModule': {'briefSummary': 'Results have indicated that some dietary fibers increase fecal fat excretion and particularly viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may contribute to body weight management.\n\nAim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of secondary endpoints are investigated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Men\n* BMI between 18.5 and 27.0 kg/m2\n* Age 20-40 years\n\nExclusion Criteria:\n\n* Intake of potatoes with main meals more frequent than 4 times per week\n* Chronic diseases (known diabetes, cardiovascular disease, irritable bowels disease, colitis ulcerosa, crohn disease, or other chronic diseases which could affect the results of the present study)\n* Gluten allergy\n* Use of daily prescription medicine (mild analgesics are allowed)\n* Use of lipid-lowering agents (e.g. Becel, HUSK)\n* Use of food supplements of relevance to the study (such as pre- and probiotics)\n* Irregular intake of vitamin /mineral supplements (two weeks prior to and during the entire study period)\n* Smoking\n* Elite athletes (\\>10 hours of strenuous physical activity per week)\n* Blood donation (\\<1 month before study commencement and during study period)\n* Participation in other clinical studies (\\<1 month before study commencement and during study period)\n* Inability (physically or psychologically) to comply with the procedures required by the protocol judged by the Investigator'}, 'identificationModule': {'nctId': 'NCT02957318', 'acronym': 'POFIBA', 'briefTitle': 'Effect of Potato Fiber on Appetite and Fecal Fat Excretion', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of Potato Fiber on Appetite and Fecal Fat Excretion', 'orgStudyIdInfo': {'id': 'B 326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FiberBind', 'interventionNames': ['Dietary Supplement: FiberBind']}, {'type': 'EXPERIMENTAL', 'label': 'RG-I fiber', 'interventionNames': ['Dietary Supplement: RG-I fiber']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'FiberBind', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Potato pulp consisting of 68% fiber (5.5 soluble, 76.7% insoluble and 17.8% resistant starch), 9.7% water, 0.3% fat, 7.2% protein and 14% carbohydrates (starch).', 'armGroupLabels': ['FiberBind']}, {'name': 'RG-I fiber', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.', 'armGroupLabels': ['RG-I fiber']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low-fiber control', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Nutrition, Exercise and Sports', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anne Birgitte Raben', 'investigatorAffiliation': 'University of Copenhagen'}}}}