Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-06 @ 2:37 PM
Study NCT ID:
NCT03844958
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2019-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Red Furu Consumption on Serum Vitamin B12 and Homocysteine Concentration In Healthy Young Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D045730', 'term': 'Soy Foods'}], 'ancestors': [{'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will apply the parallel method and volunteers will be randomized into two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2019-02-02', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Normal Dietary Nutrient Intake', 'timeFrame': '0-24-72 Hours', 'description': 'Calculated at Zhejiang University by the researcher using the Chinese Food Software'}], 'primaryOutcomes': [{'measure': 'Serum Vitamin B12', 'timeFrame': '0-24-72 Hours', 'description': 'Serum vitamin B12 concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'Serum Homocysteine', 'timeFrame': '0-24-72 Hours', 'description': 'Serum homocysteine concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}], 'secondaryOutcomes': [{'measure': 'Serum Folate', 'timeFrame': '0-24-72 Hours', 'description': 'Serum folate concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'Serum Iron', 'timeFrame': '0-24-72 Hours', 'description': 'Serum iron concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'Serum Ferritin', 'timeFrame': '0-24-72 Hours', 'description': 'Serum ferritin concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'Glucose', 'timeFrame': '0-24-72 Hours', 'description': 'Serum glucose concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'Total cholesterol', 'timeFrame': '0-24-72 Hours', 'description': 'Serum total cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'Triglyceride', 'timeFrame': '0-24-72 Hours', 'description': 'Triglyceride concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'High-density cholesterol', 'timeFrame': '0-24-72 Hours', 'description': 'High-density cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}, {'measure': 'Low-density cholesterol', 'timeFrame': '0-24-72 Hours', 'description': 'Low-density cholesterol concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Red furu', 'Metabolism', 'Randomized'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '11322691', 'type': 'BACKGROUND', 'citation': 'Han BZ, Rombouts FM, Nout MJ. A Chinese fermented soybean food. Int J Food Microbiol. 2001 Apr 11;65(1-2):1-10. doi: 10.1016/s0168-1605(00)00523-7.'}, {'pmid': '21436999', 'type': 'BACKGROUND', 'citation': 'Kwak CS, Lee MS, Oh SI, Park SC. Discovery of novel sources of vitamin b(12) in traditional korean foods from nutritional surveys of centenarians. Curr Gerontol Geriatr Res. 2010;2010:374897. doi: 10.1155/2010/374897. Epub 2011 Mar 8.'}, {'pmid': '25529671', 'type': 'BACKGROUND', 'citation': 'Xu L, Du B, Xu B. A systematic, comparative study on the beneficial health components and antioxidant activities of commercially fermented soy products marketed in China. Food Chem. 2015 May 1;174:202-13. doi: 10.1016/j.foodchem.2014.11.014. Epub 2014 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to investigate the effect of red furu (Chinese fermented soybean product) consumption on serum vitamin B12, Homocysteine concentration and other cardio-metabolic risk factors in healthy young volunteers.', 'detailedDescription': "The study will apply the parallel study method and participants will be randomized into two groups. In the randomized controlled clinical trial, twenty-three healthy young volunteers (11 females and 12 males, aged 19-39 years) were recruited from Zhejiang University, China. They were randomly assigned to two groups of either red furu (n=11, 5 females and 6 males) or tofu (n=12, 6 females and 6 males). Volunteers consumed a provided meal, either 50 g of red furu or tofu with two slices of bread for 1 day breakfast meal. Volunteers also recorded their normal dietary intake during the 3 days trial period using provided self-report food diary. Fasting blood sample was drawn at 0h, 24h and 72h. Serum VB12, Hcy and other cardio-metabolic risk factors were measured by standard methods.\n\nTest Meals:\n\nRed Furu Group: 50 g of red furu with 2 slices of bread. Tofu Group: 50 g of plain tofu eaten with 2 slices of bread. Volunteers will refrain from consumption of fermented products 1 week prior to the study. Thereafter subject feed on control diet and intervention diet for 1 day. Volunteers' normal diets and test meals will be recorded on a self-administered questionnaire, followed by testing serum vitamin B12, Homocysteine and other biochemical parameters.\n\n5-10 mL blood will be collected per session. Blood will be collected: 3 times (0h-24h-72h).Participants will be asked to fast for 10-12 hours prior to the blood draw."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-39 Years\n* All Races\n\nExclusion Criteria:\n\n* Taking antibiotics or vitamin B12 supplements within 1 month prior to enrollment'}, 'identificationModule': {'nctId': 'NCT03844958', 'briefTitle': 'Effect of Red Furu Consumption on Serum Vitamin B12 and Homocysteine Concentration In Healthy Young Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Effect of Consuming Red Furu On Serum Vitamin B12, Homocysteine And Other Cardio-Metabolic Risk Factors In Healthy Young Volunteers: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Zhejiang University T.T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Red Furu', 'description': 'Volunteer was randomized into group red furu', 'interventionNames': ['Other: Red Furu', 'Other: Tofu']}, {'type': 'EXPERIMENTAL', 'label': 'Fresh Tofu', 'description': 'Volunteer was randomized into group tofu', 'interventionNames': ['Other: Red Furu', 'Other: Tofu']}], 'interventions': [{'name': 'Red Furu', 'type': 'OTHER', 'description': '50 g red furu was consumed with 2 slices of plain bread for one-day\n\n50 g Fresh tofu was consumed with 2 slices of plain bread for one-day', 'armGroupLabels': ['Fresh Tofu', 'Red Furu']}, {'name': 'Tofu', 'type': 'OTHER', 'description': '50 g Fresh tofu was consumed with 2 slices of plain bread for one-day\n\n50 g red furu was consumed with 2 slices of plain bread for one-day', 'armGroupLabels': ['Fresh Tofu', 'Red Furu']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310058', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Duo Li, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Duo li', 'investigatorAffiliation': 'Zhejiang University'}}}}