Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT03738358
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2018-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014199', 'term': 'Trehalose'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, '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': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in liver fat content scanned by CT', 'timeFrame': 'Screening (baseline) and 12 weeks', 'description': 'Trehalose group and placebo comparator group are scanned by CT to compare the difference of liver fat content'}], 'secondaryOutcomes': [{'measure': 'Change in ALT and AST', 'timeFrame': '0 (baseline) and 12 weeks', 'description': 'Change from baseline of ALT and AST, the trend of change in blood, the proportion of subjects with normal ALT and AST level'}, {'measure': 'Change in homeostatic model assessment-insulin resistance (HOMA-IR)', 'timeFrame': 'Screening (baseline) and 12 weeks', 'description': 'Change from baseline of HOMA-IR, the trend of change in blood, the proportion of subjects with normal HOMA-IR level'}, {'measure': 'Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid', 'timeFrame': '0 (baseline), 6 and 12 weeks', 'description': 'the trend of change in blood'}, {'measure': 'Change in BMI', 'timeFrame': '0 (baseline), 6 and 12 weeks', 'description': 'BMI among subjects is measured by physical examination'}, {'measure': 'Change in visceral fat and subcutaneous fat levels', 'timeFrame': '0 week and 12 weeks', 'description': 'Both visceral fat and subcutaneous fat levels are anlayzed by CT scan.'}, {'measure': 'Adverse event (AE)', 'timeFrame': '0 week, 6 weeks, and 12 weeks', 'description': 'Symptom and signs in subjects are monitored'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver']}, 'descriptionModule': {'briefSummary': 'This clinical study will be conducted to evaluate the efficacy and safety of trehalose in patients with fatty liver disease. After 12-week intake, subjects will be checked up fat content in liver using CT scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 19-year-old and 79-year-old\n* Weight (≥50kg)\n* Is diagnosed as fatty liver on ultrasonography within 24 weeks from screening day\n* Has willingness and ability to participate whole clinical study period\n* Willing to give informed consent form\n\nExclusion Criteria:\n\n* Patient with alcoholic fatty liver\n* Patient with inflammatory bowel disease\n* Is required treatment for like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study\n* Has any medical history with virus or toxic hepatitis\n* Has any medical history of gastrointestinal surgery (except simple appendectomy \\& repair of hernia)\n* Has medical history of malignant tumor (except non-melanoma skin cancer) within the last 5 years from the screening day\n* Took any drugs (UDCA, silymarin, omega-3, fenofibrate etc.) which is decided as unsuitable drug for combined-dose by investigator\n* Over 4 times of maximum reference range of ALT or AST\n* Average drinking quantity per week \\> alcohol 140 g\n* Pregnant or nursing women\n* Is currently participating into another clinical study\n* Being made a decision from investigator as unsuitable to participate this study'}, 'identificationModule': {'nctId': 'NCT03738358', 'briefTitle': 'Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Trehalose in Patients With Fatty Liver Disease', 'orgStudyIdInfo': {'id': '2016-02-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trehalose', 'interventionNames': ['Dietary Supplement: Trehalose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Trehalose', 'type': 'DIETARY_SUPPLEMENT', 'description': '80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g', 'armGroupLabels': ['Trehalose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jung-Ryul Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}