Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-10 @ 8:22 AM
Study NCT ID:
NCT02488356
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Litramine for Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight from baseline', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'descriptionModule': {'briefSummary': 'Safety and Efficacy of Litramine in weight loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects ≥18 and ≤ 60 years of age\n* Body mass index (BMI) ≥ 25 and ≤35 kg/m2\n* Judged by the Investigator to be in general good health on the basis of medical history\n* Judged by the Investigator to be motivated to lose weight\n* Accustomed to 3 main meals per day\n* Consistent and stable body weight 3 months prior to study enrollment (±5%)\n* Consistent regular physical activity\n* Agree to stop all medications and supplements during the entire length of the study\n* Commitment to adhere to diet and lifestyle recommended for the study\n* Females of child bearing potential must agree to use appropriate birth control methods during the entire study period\n* Stable concomitant medications\n* Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator\n\nExclusion Criteria:\n\n* Presence of any active gastrointestinal disease\n\n * Malabsorption disorders\n * Pancreatitis\n * Stenosis in the GI tract\n * Bariatric surgery/Lapband and bypass surgery\n * Abdominal surgery within 6 months prior to the study\n* Subjects whose weight increases 1.5 pounds from screening to the baseline visit\n* History of eating disorders like bulimia, anorexia nervosa, binge-eating\n* Renal conditions / disease, history of nephrolithiasis\n* Cardiac diseases requiring drug therapy\n* Other serious organ or systemic diseases such as diabetes mellitus, standard laundry list of cardiac diseases\n* Osteoporosis or on medications for osteoporosis\n* Known sensitivity to the ingredients of the study medication\n* Vegetarian or Vegan\n* Daily use of dietary supplement (2 week washout is allowed)\n* Any medication that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped at least 3 months before study start)\n* Subjects who are pregnant or lactating\n* Any medication or use of products for the treatment of obesity (e.g., Xenical, other fat binder, fat burner, satiety products etc.)\n* Subjects who are currently on carbohydrate and protein diet, or low fat diet\n* More than 3 hours of strenuous physical activity per week\n* History of abuse of drugs, alcohol or medication\n* Smoking cessation within the 6 months prior to this study\n* Subjects unable to understand or follow the study protocol\n* Participation in similar study or weight loss program within 6 months prior to this study\n* Participation in other studies with in the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT02488356', 'briefTitle': 'Litramine for Weight Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'InQpharm Group'}, 'officialTitle': 'Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study', 'orgStudyIdInfo': {'id': 'INQP1200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Litramine', 'description': 'Patented fibre complex from Opuntia ficus-indica (Litramine)', 'interventionNames': ['Dietary Supplement: Litramine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inert fillers that is manufactured to look and taste the same as verum', 'interventionNames': ['Dietary Supplement: Litramine']}], 'interventions': [{'name': 'Litramine', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['IQP G-002AS'], 'armGroupLabels': ['Litramine', 'Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InQpharm Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}