Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT01590667
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2012-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Litramine on Fat Excretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-25', 'studyFirstSubmitDate': '2012-05-01', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention', 'timeFrame': '7 days per intervention', 'description': 'The amount of fat excreted in the feces will be quantified by the near-infrared reflectance analysis (NIRA)'}], 'secondaryOutcomes': [{'measure': 'Full blood count', 'timeFrame': 'Approximately 45 days', 'description': 'Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes'}, {'measure': 'Clinical chemistry', 'timeFrame': 'Approximately 45 days', 'description': 'Liver function, renal function, protein metabolism, lipid metabolism'}, {'measure': 'Blood pressure', 'timeFrame': 'Approximately 45 days', 'description': 'Sitting blood pressure and heart rate will be measured using standard devices'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fat excretion'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '25067985', 'type': 'DERIVED', 'citation': 'Uebelhack R, Busch R, Alt F, Beah ZM, Chong PW. Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation. Curr Ther Res Clin Exp. 2014 Jun 21;76:39-44. doi: 10.1016/j.curtheres.2014.02.001. eCollection 2014 Dec.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 20-30 kg/m2\n* Accustomed to 3 main meals/day\n* Commitment to avoid the use of other weight management products during study\n* Females' agreement to use appropriate birth control methods during the active study period\n* Self-reported regular bowel movement (1-2 times per day)\n* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply\n\nExclusion Criteria:\n\n* Known sensitivity to the ingredients of the device\n* Diabetes mellitus (type 1 or 2)\n* History or clinical signs of endocrine disorders\n* Clinically relevant excursions of safety parameter\n* Current use of anti-depressants\n* Presence of acute or chronic gastrointestinal disease\n* Uncontrolled hypertension (more than 160/110 mm Hg)\n* Stenosis in the gastrointestinal tract\n* Bariatric surgery\n* Abdominal surgery within the last 6 months prior to enrollment\n* History of eating disorders such as bulimia, anorexia nervosa within the past 12 months\n* Other serious organ or systemic diseases such as cancer\n* Any medication that could influence gastrointestinal functions\n* Pregnancy or nursing\n* Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment\n* History of abuse of drugs, alcohol or medication\n* Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation"}, 'identificationModule': {'nctId': 'NCT01590667', 'briefTitle': 'Effect of Litramine on Fat Excretion', 'organization': {'class': 'INDUSTRY', 'fullName': 'InQpharm Group'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects', 'orgStudyIdInfo': {'id': 'INQ/028711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Litramine', 'description': '2 tablets 3 times daily (oral consumption, 30 minutes after meal)', 'interventionNames': ['Device: Litramine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 tablets 3 times daily (oral consumption, 30 minutes after meal)', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Litramine', 'type': 'DEVICE', 'description': '2 tablets 3 times daily (oral consumption, 30 minutes after meal)', 'armGroupLabels': ['Litramine']}, {'name': 'Placebo', 'type': 'DEVICE', 'description': '2 tablets 3 times daily (oral consumption, 30 minutes after meal)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10369', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Weißenseer Weg 111', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Regina Busch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'analyze & realize AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InQpharm Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}