Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT02930668
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2016-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Glucosanol™ in Body Weight Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2016-10-10', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '38830962', 'type': 'DERIVED', 'citation': 'Jager R, Abou Sawan S, Purpura M, Grube B, Roske Y, De Costa P, Chong PW. Proprietary alpha-amylase inhibitor formulation from white kidney bean (Phaseolus vulgaris L.) promotes weight and fat loss: a 12-week, double-blind, placebo-controlled, randomized trial. Sci Rep. 2024 Jun 3;14(1):12685. doi: 10.1038/s41598-024-63443-8.'}]}, 'descriptionModule': {'briefSummary': 'It was proven in a previous clinical study that Glucosanol™ is effective and safe in reducing weight in the overweight and obese. The present study aims at expanding the data concerning the weight management effect of Glucosanol™ in overweight and moderately obese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 25 kg/m2 - 34,9 kg/m2\n* Generally in good health• Desire to lose weight\n* Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner)\n* Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change)• Readiness to take IP as recommended\n* Readiness to avoid the use of other weight loss and/or management products and/or programs during the study\n* Readiness to adhere to diet recommendation during the study\n* Readiness to keep the habitual level of physical activity as prior to the study during the study\n* Readiness and ability to complete the subject diary and study questionnaires\n* Negative pregnancy testing (beta HCG-test in urine) at V1 in women of childbearing potential\n* Women of childbearing potential: commitment to use contraception methods\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to the components of the investigational products\n* Known allergy or hypersensitivity to members of the Fabaceae family\n* Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)\n* Significant disorders:\n\n * untreated or unstable thyroid gland disorder\n * untreated or unstable hypertension (\\>140/90 mm Hg)\n * acute or chronic gastrointestinal (GI) disease or malabsorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.)\n * diabetes mellitus- coagulation disorder- any other serious organ or systemic diseases that could influence the conduct and/or out-come of the study and/or could affect the tolerability of the subject (in the opinion of the investigator)\n* Significant surgery within the last 6 months prior to V1:\n\n * GI surgery\n * liposuction\n* History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 monthsprior to V1\n* Clinically relevant excursions of safety laboratoryparameters\n* Any electronic medical implant\n* Regular use of anticoagulants\n* Regular medication and/or supplementation and/or treatment within the last 3 months prior to V1 and during the study:\n\n * that could influence body weight (e.g. systemic corticosteroids)\n * that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, anti-diarrheals etc.) as per investigator judgement\n * for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)\n* Consumption of food supplements or natural health products for the duration of the study\n* Diet to lose and/or manage weight (except ac-cording to the study protocol)\n* Vegetarian, vegan or macrobiotic diet\n* Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed)\n* Pregnancy or nursing\n* History of or current abuse of drugs, alcohol or medication\n* Inability to comply with study requirements\n* Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship\n* Participation in another clinical study in the 30 days prior to V1 and during the study"}, 'identificationModule': {'nctId': 'NCT02930668', 'briefTitle': 'Efficacy and Safety of Glucosanol™ in Body Weight Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'InQpharm Group'}, 'officialTitle': 'Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of Glucosanol™ in Reducing Body Weight in Overweight and Moderately Obese Subjects', 'orgStudyIdInfo': {'id': 'INQ/024115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo is identical in shape, colour and size to the active comparator with the active ingredient replaced with microcrystalline cellulose.\n\nSubjects will take 2 capsules three times a day, 30 mins before meals.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose (Glucosanol 350mg)', 'description': 'Each capsule contains Glucosanol / Phaselite 350mg\n\nSubjects will take 2 capsules three times a day, 30 mins before meals.', 'interventionNames': ['Dietary Supplement: Glucosanol 350mg']}, {'type': 'EXPERIMENTAL', 'label': 'High dose (Glucosanol 500mg)', 'description': 'Each capsule contains Glucosanol / Phaselite 500mg\n\nSubjects will take 2 capsules three times a day, 30 mins before meals.', 'interventionNames': ['Dietary Supplement: Glucosanol 500mg']}], 'interventions': [{'name': 'Glucosanol 350mg', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Low dose (Glucosanol 350mg)']}, {'name': 'Glucosanol 500mg', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['High dose (Glucosanol 500mg)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10709', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Barbara Grube', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Ralf Uebelhack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'analyze & realize GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InQpharm Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}