Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT06188832
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C022901', 'term': '(1-6)-alpha-glucomannan'}, {'id': 'D007444', 'term': 'Inulin'}, {'id': 'D011620', 'term': 'Psyllium'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005630', 'term': 'Fructans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body-weight change in %', 'timeFrame': '180 days'}], 'secondaryOutcomes': [{'measure': 'body-weight reduction ≥5%', 'timeFrame': '180 days'}, {'measure': 'body-weight reduc-tion ≥10%', 'timeFrame': '180 days'}, {'measure': 'Body weight in kg', 'timeFrame': '180 days'}, {'measure': 'Body mass index change in %', 'timeFrame': '180 days'}, {'measure': 'Fat mass change in %', 'timeFrame': '180 days'}, {'measure': 'Systolic blood pressure in mmHg', 'timeFrame': '180 days'}, {'measure': 'Fat-free mass change in kg', 'timeFrame': '180 days'}, {'measure': 'Visceral fat rating change from baseline', 'timeFrame': '180 days'}, {'measure': 'Diastolic blood pressure in mmHg', 'timeFrame': '180 days'}, {'measure': 'Total cholesterol ratio', 'timeFrame': '180 days'}, {'measure': 'LDL-C ratio', 'timeFrame': '180 days'}, {'measure': 'HDL-C ratio', 'timeFrame': '180 days'}, {'measure': 'Triglycerides ratio', 'timeFrame': '180 days'}, {'measure': 'hsCRP ratio', 'timeFrame': '180 days'}, {'measure': 'Fasting plasma glucose mmol/l', 'timeFrame': '180 days'}, {'measure': 'Side effects %', 'timeFrame': '180 days', 'description': 'any side effects or adverse events reported by subjects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'supplements', 'body mass index', 'overweight'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '38398881', 'type': 'RESULT', 'citation': 'Pokushalov E, Ponomarenko A, Garcia C, Pak I, Shrainer E, Seryakova M, Johnson M, Miller R. The Impact of Glucomannan, Inulin, and Psyllium Supplementation (SolowaysTM) on Weight Loss in Adults with FTO, LEP, LEPR, and MC4R Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024 Feb 17;16(4):557. doi: 10.3390/nu16040557.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/38398881/', 'label': '10.3390/nu16040557'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR).\n* Overweight or obese status (BMI ≥ 25).\n\nExclusion Criteria:\n\n\\- BMI \\< 25'}, 'identificationModule': {'nctId': 'NCT06188832', 'acronym': 'SOLFIBERGP', 'briefTitle': 'Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms', 'organization': {'class': 'OTHER', 'fullName': 'S.LAB (SOLOWAYS)'}, 'officialTitle': 'Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms', 'orgStudyIdInfo': {'id': 'SW003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiber Supplementation', 'description': 'The active powder contained 1g glucomannan, 1g inulin, and 3g psyllium per bag.', 'interventionNames': ['Dietary Supplement: glucomannan, inulin, and psyllium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The placebo powder composed of maltodextrin and rice flour, carefully selected to mimic the texture and volume of the active powder without providing any active dietary fiber', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'glucomannan, inulin, and psyllium', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium', 'armGroupLabels': ['Fiber Supplementation']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'the subjects recieved placebo', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630090', 'city': 'Novosibirsk', 'state': 'Novosibisk Region', 'country': 'Russia', 'facility': 'Center of New Medical Technologies', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.LAB (SOLOWAYS)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center of New Medical Technologies', 'class': 'OTHER'}, {'name': 'Triangel Scientific', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}