Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 7:32 AM
Study NCT ID:
NCT00953004
Status:
UNKNOWN
Last Update Posted:
2010-11-11
First Post:
2009-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flax Mucilage and Apparent Nutrient Digestibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-10', 'studyFirstSubmitDate': '2009-07-17', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat and energy digestibility', 'timeFrame': 'mean over period'}], 'secondaryOutcomes': [{'measure': 'appetite', 'timeFrame': 'three times daily'}, {'measure': 'gastrointestinal distress', 'timeFrame': 'continously'}, {'measure': 'lipid profile', 'timeFrame': 'end of each period'}, {'measure': 'glucose and insulin', 'timeFrame': 'end of each period'}, {'measure': 'fecal output and transit time', 'timeFrame': 'mean of each period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dietary fiber', 'obesity', 'apparent energy digestibility'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '22305169', 'type': 'DERIVED', 'citation': 'Kristensen M, Jensen MG, Aarestrup J, Petersen KE, Sondergaard L, Mikkelsen MS, Astrup A. Flaxseed dietary fibers lower cholesterol and increase fecal fat excretion, but magnitude of effect depend on food type. Nutr Metab (Lond). 2012 Feb 3;9:8. doi: 10.1186/1743-7075-9-8.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to study the effects of flaxseed mucilage, rich in dietary fiber on apparent fat and energy digestibility in young adults.', 'detailedDescription': 'A 3 times 1-wk randomised crossover dietary intervention study, where the full diet is provided to 17 young subjects along with different flaxseed mucilage preparations. During the last five days, fecal samples are collected. Fasting blood samples are collected on day 1 and 8 in each period and appetite sensation is registered three times daily before the main meals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40y\n* BMI 22-28\n* healthy\n\nExclusion Criteria:\n\n* smoking\n* medication\n* excess PA'}, 'identificationModule': {'nctId': 'NCT00953004', 'acronym': 'HØRFRØ', 'briefTitle': 'Flax Mucilage and Apparent Nutrient Digestibility', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of Flaxseed and Flaxseed Mucilage on Energy Digestibility, Lipid Profile and Appetite', 'orgStudyIdInfo': {'id': 'B245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fiber drink', 'interventionNames': ['Dietary Supplement: fiber drink and fiber bread']}, {'type': 'EXPERIMENTAL', 'label': 'fiber bread', 'interventionNames': ['Dietary Supplement: fiber drink and fiber bread']}, {'type': 'EXPERIMENTAL', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: fiber drink and fiber bread']}], 'interventions': [{'name': 'fiber drink and fiber bread', 'type': 'DIETARY_SUPPLEMENT', 'description': 'fiber drink or fiber bread three times daily', 'armGroupLabels': ['fiber bread', 'fiber drink', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1958', 'city': 'Frederiksberg C', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department og Human Nutrition'}], 'overallOfficials': [{'name': 'Arne Astrup, PhD, Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Head and professor Arne Astrup', 'oldOrganization': 'University of Copenhagen, Department of Human Nutrition'}}}}