Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT03429920
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2018-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Both the participants and the investigators will not be aware of which powder is the active powder and which one is the placebo. Only the Principle Investigator will be made aware.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This dietary intervention trial is a randomized, 2x2 crossover design with 24 subjects in free-living conditions.There will be a two week run-in (acclimation period), after which subjects will be randomized to receive either Q CAN powder or placebo powder for 12 weeks. Following a two week wash out period, subjects will be switched over to the alternate treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2018-02-09', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test the effects of Q CAN PLUS powder, on serum lipids', 'timeFrame': 'baseline to 7 months', 'description': 'This is a composite measurement which will measure the change in the levels of serum Low Density Cholesterol, High Density Cholesterol, ApoLipoprotein A and B, APO E Allele genetic typing and triglycerides before the ingestion of QCAN PLUS powder and at 7 months after ingestion of Q CAN PLUS powder.'}, {'measure': 'Inflammatory parameter', 'timeFrame': 'baseline to 7 months', 'description': 'to test the changes in concentration of hs-CRP (highly sensitive C reactive protein) in the blood prior to ingestion of Q CAN PLUS powder and again at 7 months after ingestion of Q CAN PLUS Powder'}], 'secondaryOutcomes': [{'measure': 'Fasting Glucose', 'timeFrame': 'baseline to 7 months', 'description': 'to test the changes in the concentration of fasting glucose levels in the blood prior to ingestion of Q CAN PLUS powder and again after 7 months after ingestion of QCAN PLUS powder'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fermented Soy', 'Cardiovascular Disease', 'Inflammation', 'DNA Methylation'], 'conditions': ['Cardiovascular Risk Factor', 'Heart Diseases', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '33562090', 'type': 'DERIVED', 'citation': 'Jung SM, Haddad EH, Kaur A, Sirirat R, Kim AY, Oda K, Rajaram S, Sabate J. A Non-Probiotic Fermented Soy Product Reduces Total and LDL Cholesterol: A Randomized Controlled Crossover Trial. Nutrients. 2021 Feb 6;13(2):535. doi: 10.3390/nu13020535.'}]}, 'descriptionModule': {'briefSummary': 'This research study will test the effects of Q CAN PLUS powder on serum lipids, selected inflammatory and oxidative parameters and genome-wide methylation', 'detailedDescription': 'The purpose of this research study is to investigate the effects of a dietary supplement from soybeans that might help in managing heart disease. The rationale for this study is to reduce the risk factors of heart disease in high risk individuals by using soy supplements. The dietary supplement intervention trial is a randomized, 2x2 cross over design with 24 subjects in free-living conditions. There will be a two week run-in (acclimation period) after which subjects will be randomized to receive either QCAN powder or placebo powder for 12 weeks. Following a two week wash out period, subjects will be switched over(cross over) to alternate treatment. Thus, the interventions of the study will last for a total of 28 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 29-75 years of age\n* At high risk for cardiovascular disease, i.e. with 2 or more risk factors:\n* Present tobacco smoker\n* Arterial hypertension (BP ≥ 140/90 mm Hg or treatment)\n* LDL-cholesterol ≥ 110 mg/dl\n* HDL-cholesterol ≤ 40 mg/dl\n* Triglycerides ≥ 150 mg/dl\n* Fasting blood glucose ≥ 110 mg/dl\n* Overweight or obesity (BMI ≥ 25 kg/m2)\n* Family history of premature heart disease\n\nExclusion Criteria:\n\n* Uncontrolled renal, hepatic, or endocrine disease\n* Abnormal blood chemistry profile\n* Familial hypercholesterolemia or other genetic dyslipidemia\n* Intake of lipid-lowering drugs and dietary products including plant sterols/stanols\n* High Framingham risk or medical condition in which statin therapy is considered necessary by a treating physician\n* Hypersensitive or allergic to soy or cellulose\n* Alcohol or drug addiction or abuse\n* Diabetes\n* Lack of ability or interest to follow the dietary intervention'}, 'identificationModule': {'nctId': 'NCT03429920', 'acronym': 'FS', 'briefTitle': 'Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'The Effect of Fermented Soy Based Dietary Food Product on Cardiometabolic Risk Factors in Individuals at High Risk of Cardiovascular Disease', 'orgStudyIdInfo': {'id': '5180083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Q CAN PLUS POWDER', 'description': 'QCAN PLUS POWDER:2 pouches per day, each pouch contains(12-15gms of fermented soy powder)', 'interventionNames': ['Dietary Supplement: Q CAN PLUS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Sprouted brown rice protein with flavor (provided by BESO Biological Research Inc.)', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Q CAN PLUS', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy', 'armGroupLabels': ['Q CAN PLUS POWDER']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Joan Sabate, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition', 'investigatorFullName': 'Joan Sabate,DrPH, MD', 'investigatorAffiliation': 'Loma Linda University'}}}}